Page last updated: 2024-11-07

spironolactone and Acute Kidney Failure

spironolactone has been researched along with Acute Kidney Failure in 44 studies

Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)
spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.

Research Excerpts

ExcerptRelevanceReference
"In patients with heart failure receiving optimal therapy, WRF and HK were more frequent when eplerenone was added, but their occurrence did not eliminate the survival benefit of eplerenone."9.19Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from ( Bakris, G; Dobre, D; Girerd, N; Krum, H; McMurray, JJ; Messig, M; Pitt, B; Rossignol, P; Shi, H; Swedberg, K; van Veldhuisen, DJ; Vincent, J; Zannad, F, 2014)
"To quantify the risk of hyperkalemia and acute kidney injury (AKI) when spironolactone use is added on to loop diuretic use among patients with heart failure, and to evaluate whether the risk is modified by level of kidney function."7.96Hyperkalemia and Acute Kidney Injury with Spironolactone Use Among Patients with Heart Failure. ( Alexander, GC; Chang, AR; Coresh, J; Grams, ME; Inker, LA; Qiao, Y; Secora, AM; Shin, JI, 2020)
"Our results show that MR antagonism administered, either immediately or 3 h after I/R, effectively prevented ischemic acute renal injury, indicating that spironolactone is a promising agent for preventing acute kidney injury once an ischemic insult has occurred."7.78Recovery from ischemic acute kidney injury by spironolactone administration. ( Barrera-Chimal, J; Bobadilla, NA; Cruz, C; Gamba, G; Garzón-Muvdi, J; Pérez-Villalva, R; Rodríguez-Romo, R; Sánchez-Pozos, K, 2012)
"The renal tubular necrosis and calcification as well as the mortality induced by mercuric chloride in the rat are readily prevented by prior treatment with well-tolerated amounts of spironolactone."7.65Mercury poisoning: prevention by spironolactone. ( Selye, H, 1970)
"Treatment with spironolactone either before or after ischemia prevented subsequent CKD by avoiding the activation of fibrotic and inflammatory pathways."5.39Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury. ( Barrera-Chimal, J; Bobadilla, NA; Gamba, G; Pérez-Villalva, R; Reyna, J; Rodríguez-Romo, R; Uribe, N, 2013)
"In patients with heart failure receiving optimal therapy, WRF and HK were more frequent when eplerenone was added, but their occurrence did not eliminate the survival benefit of eplerenone."5.19Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from ( Bakris, G; Dobre, D; Girerd, N; Krum, H; McMurray, JJ; Messig, M; Pitt, B; Rossignol, P; Shi, H; Swedberg, K; van Veldhuisen, DJ; Vincent, J; Zannad, F, 2014)
" Spironolactone, furosemide, and trimethoprim with sulfamethoxazole are medicines that, in particular, need to be used carefully and monitored closely in patients in the community at risk of acute kidney injury."4.12Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case-Control Study with a Focus on Medicines Used in Primary Care. ( Kassie, GM; Kerr, M; Moffat, A; Pratt, N; Roughead, EE, 2022)
"To quantify the risk of hyperkalemia and acute kidney injury (AKI) when spironolactone use is added on to loop diuretic use among patients with heart failure, and to evaluate whether the risk is modified by level of kidney function."3.96Hyperkalemia and Acute Kidney Injury with Spironolactone Use Among Patients with Heart Failure. ( Alexander, GC; Chang, AR; Coresh, J; Grams, ME; Inker, LA; Qiao, Y; Secora, AM; Shin, JI, 2020)
"Our results show that MR antagonism administered, either immediately or 3 h after I/R, effectively prevented ischemic acute renal injury, indicating that spironolactone is a promising agent for preventing acute kidney injury once an ischemic insult has occurred."3.78Recovery from ischemic acute kidney injury by spironolactone administration. ( Barrera-Chimal, J; Bobadilla, NA; Cruz, C; Gamba, G; Garzón-Muvdi, J; Pérez-Villalva, R; Rodríguez-Romo, R; Sánchez-Pozos, K, 2012)
"Despite a marked increased in the use of spironolactone in patients with and without heart failure, no increase was seen in hospital admissions for hyperkalaemia and outpatient hyperkalaemia actually fell."3.76Spironolactone use and renal toxicity: population based longitudinal analysis. ( Fahey, T; Macdonald, TM; Struthers, AD; Watson, AD; Wei, L, 2010)
"A 75-year-old man with post-MI heart failure and an ejection fraction of 15 % was treated with an ACE-inhibitor, spironolactone and a beta-blocker."3.76[An elderly man with known heart failure admitted with cardiogenic shock]. ( Fagerheim, AK; Hardersen, R; Hovland, A; Nielsen, EW, 2010)
"In 3 patients with severe cardiac failure high dose therapy with the ACE inhibitor enalapril was instituted during a state of extracellular volume depletion."3.67[Severe complications during enalapril therapy for heart insufficiency]. ( Stäubli, M; Wieland, T, 1988)
"Acute reversible renal failure with hyperkalemia developed in a 42-year-old woman during treatment of heart failure and hypertension with high doses of enalapril and diuretics."3.67[Acute reversible kidney insufficiency due to enalapril during diuretic-treated heart insufficiency]. ( Degenhardt, S, 1987)
"The renal tubular necrosis and calcification as well as the mortality induced by mercuric chloride in the rat are readily prevented by prior treatment with well-tolerated amounts of spironolactone."3.65Mercury poisoning: prevention by spironolactone. ( Selye, H, 1970)
"However, incidence of postoperative low cardiac output state (p < 0."1.48Preoperative aldosterone receptor blockade and outcomes of cardiac surgery in patients with chronic kidney disease
. ( Bitran, D; Fink, D; Merin, O; Shavit, L; Silberman, S; Tauber, R, 2018)
"Spironolactone was the predominantly prescribed aldosterone antagonist."1.43Effectiveness and Safety of Aldosterone Antagonist Therapy Use Among Older Patients With Reduced Ejection Fraction After Acute Myocardial Infarction. ( Das, S; de Lemos, JA; Fonarow, GC; Peng, SA; Peterson, ED; Vora, AN; Wang, TY, 2016)
" The aim of this study was to assess whether appropriate dosage adjustments were made in hospitalized patients with renal impairment."1.42Drug dosage adjustment in hospitalized patients with renal impairment at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia. ( Getachew, H; Shibeshi, W; Tadesse, Y, 2015)
"In patients with congestive heart failure (CHF), use of loop diuretic therapy may result in acute kidney insufficiency (AKI)."1.39Predisposing factors for acute kidney injury in Hispanic patients treated with diuretics for decompensated heart failure. ( Cangiano, JL; López, JE; Marmorato, R; Pagán, P; Ramírez, T; Ricci, F; Soto-Salgado, M; Vega, J, 2013)
"Treatment with spironolactone either before or after ischemia prevented subsequent CKD by avoiding the activation of fibrotic and inflammatory pathways."1.39Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury. ( Barrera-Chimal, J; Bobadilla, NA; Gamba, G; Pérez-Villalva, R; Reyna, J; Rodríguez-Romo, R; Uribe, N, 2013)
"Hypertension is a major risk factor for the development and progression of chronic kidney disease (CKD)."1.38Long-term effects of aldosterone blockade in resistant hypertension associated with chronic kidney disease. ( Acelajado, MC; Calhoun, DA; Cartmill, FR; Cofield, SS; Dell'Italia, LJ; Dudenbostel, T; Oparil, S; Pisoni, R, 2012)
"NSAID are frequently prescribed in elderly patients treated with ACEI or ARB in combination with diuretics."1.35Exposure of the elderly to potential nephrotoxic drug combinations in Belgium. ( De Haes, JF; De Swaef, A; Jorens, PG; Smets, HL; Verpooten, GA, 2008)

Research

Studies (44)

TimeframeStudies, this research(%)All Research%
pre-199011 (25.00)18.7374
1990's1 (2.27)18.2507
2000's2 (4.55)29.6817
2010's27 (61.36)24.3611
2020's3 (6.82)2.80

Authors

AuthorsStudies
Roughead, EE1
Kerr, M1
Moffat, A1
Kassie, GM1
Pratt, N1
Secora, AM1
Shin, JI1
Qiao, Y1
Alexander, GC1
Chang, AR1
Inker, LA1
Coresh, J1
Grams, ME1
Watanabe, K1
Hamada, T1
Shimada, K1
Fujimaru, T1
Ito, Y1
Nagahama, M1
Taki, F1
Nakayama, M1
Madero, M2
Vazquez-Rangel, A2
Gamba, G6
Zhang, W2
Xue, F1
Chu, HC1
Shavit, L1
Silberman, S1
Tauber, R1
Merin, O1
Bitran, D1
Fink, D1
Barrera-Chimal, J6
Rocha, L1
Amador-Martínez, I1
Pérez-Villalva, R5
González, R1
Cortés-González, C2
Uribe, N2
Ramírez, V1
Berman, N1
Bobadilla, NA6
Ojeda-Cervantes, M2
Alberú, J1
Morales-Buenrostro, LE2
Ricci, F1
Ramírez, T1
Marmorato, R1
Vega, J1
Pagán, P1
López, JE1
Soto-Salgado, M1
Cangiano, JL1
Chou, YH1
Lin, SL1
Rossignol, P2
Dobre, D1
McMurray, JJ1
Swedberg, K1
Krum, H1
van Veldhuisen, DJ1
Shi, H1
Messig, M1
Vincent, J1
Girerd, N1
Bakris, G1
Pitt, B1
Zannad, F2
Fiuzat, M1
Burnett, JC1
Calvier, L1
Martinez-Martinez, E1
Miana, M1
Cachofeiro, V1
Rousseau, E1
Sádaba, JR1
López-Andrés, N1
Getachew, H1
Tadesse, Y1
Shibeshi, W1
Riegel, W1
Krüger, B1
Wang, TY1
Vora, AN1
Peng, SA1
Fonarow, GC1
Das, S1
de Lemos, JA1
Peterson, ED1
Barba-Navarro, R1
Tapia-Silva, M1
Garza-Garcia, C1
López-Giacoman, S1
Melgoza-Toral, I1
Bazúa-Valenti, S1
Bobadilla, N1
Wasung de Lay, M1
Baranda, F1
Chawla, LS1
Bar-Nur, D1
Jaber, BL1
Smets, HL1
De Haes, JF1
De Swaef, A1
Jorens, PG1
Verpooten, GA1
Wei, L1
Struthers, AD1
Fahey, T1
Watson, AD1
Macdonald, TM1
Hovland, A1
Fagerheim, AK1
Hardersen, R1
Nielsen, EW1
Kawarazaki, H1
Ando, K1
Fujita, M1
Matsui, H1
Nagae, A1
Muraoka, K1
Kawarasaki, C1
Fujita, T2
Pisoni, R1
Acelajado, MC1
Cartmill, FR1
Dudenbostel, T1
Dell'Italia, LJ1
Cofield, SS1
Oparil, S1
Calhoun, DA1
Kawarazaki, W1
Nagase, M1
Yoshida, S1
Takeuchi, M1
Ishizawa, K1
Ayuzawa, N1
Ueda, K1
Sánchez-Pozos, K1
Garzón-Muvdi, J1
Rodríguez-Romo, R2
Cruz, C1
Latus, J1
Braun, N1
Alscher, MD1
Kimmel, M1
Billings, FT1
Pretorius, M1
Schildcrout, JS1
Mercaldo, ND1
Byrne, JG1
Ikizler, TA1
Brown, NJ1
Reyna, J1
Zhou, Q1
Liu, K1
Wu, H1
Chen, L1
Pouranan, V1
Yuan, M1
Xiao, Z1
Peng, W1
Xiang, A1
Tang, R1
Wrenger, E1
Müller, R1
Moesenthin, M1
Welte, T1
Frölich, JC1
Neumann, KH1
Priebe, HJ1
Hancock, EW1
Davies, DL1
Wilson, GM1
Krumlovsky, FA1
del Greco, F1
Wieland, T1
Stäubli, M1
Degenhardt, S1
Bodin, F1
Liguory, C1
Capelle, P1
Conte, M1
Raynaud, R1
Brochier, M1
Raynaud, P1
Fauchier, JP1
Frazier, HS1
Yager, H1
Căruntu, M1
Mihail, A1
Selye, H1
Lieberman, FL1
Reynolds, TB1

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure[NCT00232180]Phase 32,743 participants (Actual)Interventional2006-03-31Completed
A Non-interventional, Multicenter, Observational Clinical Trial to Assess Eplerenone Treatment in Patients With Heart Failure.[NCT02344199]450 participants (Actual)Observational2015-03-31Completed
Phase III, Single-Center, Open Label, Trial Evaluating the Safety and Efficacy of PectaSol-C Modified Citrus Pectin on PSA Kinetics in Prostate Cancer in the Setting of Serial Increases in PSA[NCT01681823]Phase 260 participants (Actual)Interventional2013-06-30Completed
Pilot Non Randomised Controlled Trial of Short Term Spironolactone Use for Prevention of Acute Kidney Injury After Cardiac Surgery[NCT02417896]150 participants (Anticipated)Interventional2013-04-30Recruiting
Usefulness of Spironolactone for the Prevention of Acute Kidney Injury in Critically Ill Patients With Invasive Mechanical Ventilation[NCT03206658]Phase 390 participants (Anticipated)Interventional2017-08-01Not yet recruiting
RAAS, Inflammation, and Post-operative AF[NCT00141778]Phase 2/Phase 3455 participants (Actual)Interventional2005-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)

Interventionparticipants (Number)
Eplerenone: Double-blind Phase288
Placebo: Double-blind Phase392

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)

Interventionparticipants (Number)
Eplerenone: Double-blind Phase249
Placebo: Double-blind Phase356

Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)

Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase408463
Placebo: Double-blind Phase491552

Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)

Death due to any cause. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase171205
Placebo: Double-blind Phase213253

Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)

Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase462530
Placebo: Double-blind Phase569636

Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)

Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase270311
Placebo: Double-blind Phase376418

Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)

First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase304346
Placebo: Double-blind Phase399439

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase147178
Placebo: Double-blind Phase185215

Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)

(NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase4549
Placebo: Double-blind Phase3340

Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)

(NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase2124
Placebo: Double-blind Phase2631

Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)

First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase164186
Placebo: Double-blind Phase253277

Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)

Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase170194
Placebo: Double-blind Phase262287

Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)

First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase44
Placebo: Double-blind Phase33

Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)

First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase910
Placebo: Double-blind Phase810

Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)

First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase6176
Placebo: Double-blind Phase5978

Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)

First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 1364, 1373)Up to 59.5 months (complete DB) (n= 1367, 1376)
Eplerenone: Double-blind Phase3345
Placebo: Double-blind Phase4153

Number of Participants With New Onset Atrial Fibrillation or Flutter

New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 950, 937)Up to 59.5 months (complete DB) (n= 956, 940)
Eplerenone: Double-blind Phase3241
Placebo: Double-blind Phase5259

Number of Participants With New Onset Diabetes Mellitus (DM)

The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

,
Interventionparticipants (Number)
Up to 50 months (cut-off) (n= 904, 973)Up to 59.5 months (complete DB) (n= 907, 975)
Eplerenone: Double-blind Phase3442
Placebo: Double-blind Phase4047

Acute Renal Failure

Percentage of patients with a creatinine concentrations >2.5mg/dl (NCT00141778)
Timeframe: Measured until the time of hospital discharge, from 5.7 to 6.8 days on average, depending on the study group.

Interventionpercentage of patients (Number)
Placebo5.4
Ramipril0.7
Spironolactone0.7

Death

The percentage of patients in each study arm who died. (NCT00141778)
Timeframe: Measured until the time of hospital discharge

Interventionpercentage of patients (Number)
Placebo1.4
Ramipril2.0
Spironolactone0

Hypokalemia

Percentage of patients who had a serum potassium concentrations <3.5 milliequivalents (mEq)/L (NCT00141778)
Timeframe: Measured until the time of hospital discharge, which was an average of 5.7 to 6.8 days depending on the treatment arm.

Interventionpercentage of patients (Number)
Placebo11.6
Ramipril13.8
Spironolactone6.8

Hypotension

Percentage of patients with hypotension defined as a systolic blood pressure <90 mmHg and/or prolonged requirement for vasopressor use. (NCT00141778)
Timeframe: Measured during and after surgery, until discharge, from 5.7 to 6.8 days on average.

Interventionpercentage of patients (Number)
Placebo5.4
Ramipril10.6
Spironolactone10.2

Length of Hospital Stay (Days)

(NCT00141778)
Timeframe: Measured from the day of surgery until the time of hospital discharge

Interventiondays (Mean)
Placebo6.8
Ramipril5.7
Spironolactone5.8

Postoperative Atrial Fibrillation

The primary endpoint of the study was the percentage of patients with electrocardiographically confirmed AF of at least 10 secs duration at any time following the end of surgery until hospital discharge, an average from 5.7 days in the ramipril group to 6.8 days in the placebo group. Patients were monitored continuously on telemetry throughout the postoperative period until discharge. Electrocardiograms were obtained for any rhythm changes detected on telemetry monitoring, and in addition, electrocardiograms were performed preoperatively, at admission to the intensive care unit, and daily starting on postoperative day 1. All electrocardiograms and rhythm strips were reviewed in a blinded fashion by a single cardiac electrophysiologist. (NCT00141778)
Timeframe: Measured from admission to the ICU until discharge from hospital

Interventionpercentage of patients (Number)
Placebo27.2
Ramipril27.8
Spironolactone25.9

Stroke

Percentage of patients in each study group who experience a cerebrovascular event, confirmed by CT. (NCT00141778)
Timeframe: Measured until the time of hospital discharge, from 5.7 to 6.8 days on average depending on the study arm.

Interventionpercentage of patients (Number)
Placebo2.7
Ramipril1.3
Spironolactone2.0

Time to Tracheal Extubation

It is the time in minutes that it took to extubate the patient after surgery. (NCT00141778)
Timeframe: It is the time (in minutes) from admission to the ICU until tracheal extubation

Interventionminutes (Mean)
Placebo1091.3
Ramipril970.1
Spironolactone576.4

Perioperative C-reactive Protein (CRP) Concentrations

C-reactive protein was measured at several time points (see table) over the course of the study. (NCT00141778)
Timeframe: Perioperative period

,,
Interventionug/mL (Mean)
Initiation of surgeryPostoperative day 1Postoperative day 2Postoperative day 3Postoperative day 4
Placebo4.151.4134.8128.394.1
Ramipril4.349.9131.0164.8105.2
Spironolactone3.964.3127.8189.4126.5

Perioperative Interleukin(IL)-6 Concentrations

Interleukin-6 was measured at several time points (see time points in table) over the course of the study (NCT00141778)
Timeframe: Perioperative period

,,
Interventionpg/ml (Mean)
Initiation of surgery30min intraop60min intraopPostopPostoperative day 1Postoperative day 2
Placebo4.712.015.6130.0119.0100.3
Ramipril4.620.528.8202.1171.095.5
Spironolactone6.611.317.4145.7164.9109.6

Perioperative Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations

Plasminogen activator inhibitor-1 (PAI-1) was measured at several time points (see table) over the course of the study. (NCT00141778)
Timeframe: Perioperative period

,,
Interventionng/mL (Mean)
Initiation of surgery30min intraop60min intraopPostopPostoperative day 1Postoperative day 2
Placebo19.619.221.036.455.228.1
Ramipril16.219.722.038.947.925.7
Spironolactone17.317.320.134.048.931.0

Reviews

4 reviews available for spironolactone and Acute Kidney Failure

ArticleYear
[Dialysis and renal transplantation: update 2015].
    Deutsche medizinische Wochenschrift (1946), 2015, Volume: 140, Issue:24

    Topics: Acute Kidney Injury; Adrenergic beta-Antagonists; Anticoagulants; Evidence-Based Medicine; Germany;

2015
Diuretics.
    International anesthesiology clinics, 1984,Spring, Volume: 22, Issue:1

    Topics: Acetazolamide; Acute Kidney Injury; Chlorothiazide; Diuretics; Diuretics, Osmotic; Ethacrynic Acid;

1984
Diuretics: mechanism of action and clinical application.
    Drugs, 1975, Volume: 9, Issue:3

    Topics: Acute Kidney Injury; Amiloride; Animals; Benzothiadiazines; Diabetes Insipidus; Diuretics; Diuretics

1975
The clinical use of diuretics. 2.
    The New England journal of medicine, 1973, Mar-01, Volume: 288, Issue:9

    Topics: Acute Kidney Injury; Diabetes Insipidus; Diuretics; Ethacrynic Acid; Furosemide; Humans; Hypertensio

1973

Trials

3 trials available for spironolactone and Acute Kidney Failure

ArticleYear
Mineralocorticoid receptor blockade reduced oxidative stress in renal transplant recipients: a double-blind, randomized pilot study.
    American journal of nephrology, 2013, Volume: 37, Issue:5

    Topics: Acute Kidney Injury; Adult; Biomarkers; Double-Blind Method; Female; Humans; Kidney Function Tests;

2013
Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from
    Circulation. Heart failure, 2014, Volume: 7, Issue:1

    Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Eplerenone; Female; Follow-Up Studies; Glomerular Filt

2014
Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from
    Circulation. Heart failure, 2014, Volume: 7, Issue:1

    Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Eplerenone; Female; Follow-Up Studies; Glomerular Filt

2014
Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from
    Circulation. Heart failure, 2014, Volume: 7, Issue:1

    Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Eplerenone; Female; Follow-Up Studies; Glomerular Filt

2014
Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from
    Circulation. Heart failure, 2014, Volume: 7, Issue:1

    Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Eplerenone; Female; Follow-Up Studies; Glomerular Filt

2014
The Effect of Spironolactone on Acute Kidney Injury After Cardiac Surgery: A Randomized, Placebo-Controlled Trial.
    American journal of kidney diseases : the official journal of the National Kidney Foundation, 2017, Volume: 69, Issue:2

    Topics: Acute Kidney Injury; Cardiac Surgical Procedures; Double-Blind Method; Female; Humans; Intensive Car

2017

Other Studies

37 other studies available for spironolactone and Acute Kidney Failure

ArticleYear
Medicine-Induced Acute Kidney Injury Findings from Spontaneous Reporting Systems, Sequence Symmetry Analysis and a Case-Control Study with a Focus on Medicines Used in Primary Care.
    Drug safety, 2022, Volume: 45, Issue:11

    Topics: Acute Kidney Injury; Adverse Drug Reaction Reporting Systems; Amlodipine; Amphotericin B; Australia;

2022
Hyperkalemia and Acute Kidney Injury with Spironolactone Use Among Patients with Heart Failure.
    Mayo Clinic proceedings, 2020, Volume: 95, Issue:11

    Topics: Acute Kidney Injury; Adult; Aged; Diuretics; Female; Follow-Up Studies; Heart Failure; Humans; Hyper

2020
Efficacy of renin-angiotensin-aldosterone system blockades for acute phase hypertensive emergencies in patient complicating severe acute kidney injury.
    CEN case reports, 2022, Volume: 11, Issue:1

    Topics: Acute Kidney Injury; Adult; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibito

2022
In Reply to 'Assessing the Effect of Spironolactone on Acute Kidney Injury After Cardiac Surgery'.
    American journal of kidney diseases : the official journal of the National Kidney Foundation, 2017, Volume: 70, Issue:1

    Topics: Acute Kidney Injury; Cardiac Surgical Procedures; Humans; Spironolactone

2017
Assessing the Effect of Spironolactone on Acute Kidney Injury After Cardiac Surgery.
    American journal of kidney diseases : the official journal of the National Kidney Foundation, 2017, Volume: 70, Issue:1

    Topics: Acute Kidney Injury; Cardiac Surgical Procedures; Humans; Spironolactone

2017
Preoperative aldosterone receptor blockade and outcomes of cardiac surgery in patients with chronic kidney disease
.
    Clinical nephrology, 2018, Volume: 89, Issue:3

    Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Cardiac Output, Low; Cardiac Surgical Procedures; Fema

2018
Delayed spironolactone administration prevents the transition from acute kidney injury to chronic kidney disease through improving renal inflammation.
    Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2019, 05-01, Volume: 34, Issue:5

    Topics: Acute Kidney Injury; Animals; Delayed-Action Preparations; Disease Models, Animal; Disease Progressi

2019
Predisposing factors for acute kidney injury in Hispanic patients treated with diuretics for decompensated heart failure.
    Puerto Rico health sciences journal, 2013, Volume: 32, Issue:2

    Topics: Acute Kidney Injury; Adult; Aged; Blood Urea Nitrogen; Creatinine; Diabetes Mellitus; Drug Utilizati

2013
The authors reply.
    Kidney international, 2013, Volume: 84, Issue:2

    Topics: Acute Kidney Injury; Animals; Ischemia; Male; Renal Insufficiency, Chronic; Spironolactone

2013
How to confirm the specific effect of spironolactone in chronic kidney disease caused by ischemic acute kidney injury?
    Kidney international, 2013, Volume: 84, Issue:2

    Topics: Acute Kidney Injury; Animals; Ischemia; Male; Renal Insufficiency, Chronic; Spironolactone

2013
Biomarkers, mineralocorticoid receptor antagonism, and cardiorenal remodeling.
    JACC. Heart failure, 2015, Volume: 3, Issue:1

    Topics: Acute Kidney Injury; Animals; Galectin 3; Heart Failure; Interleukins; Male; Myocardial Infarction;

2015
The impact of galectin-3 inhibition on aldosterone-induced cardiac and renal injuries.
    JACC. Heart failure, 2015, Volume: 3, Issue:1

    Topics: Acute Kidney Injury; Aldosterone; Animals; Disease Models, Animal; Enzyme-Linked Immunosorbent Assay

2015
Drug dosage adjustment in hospitalized patients with renal impairment at Tikur Anbessa specialized hospital, Addis Ababa, Ethiopia.
    BMC nephrology, 2015, Oct-07, Volume: 16

    Topics: Acute Kidney Injury; Adolescent; Adult; Aged; Aged, 80 and over; Allopurinol; Anti-Arrhythmia Agents

2015
Effectiveness and Safety of Aldosterone Antagonist Therapy Use Among Older Patients With Reduced Ejection Fraction After Acute Myocardial Infarction.
    Journal of the American Heart Association, 2016, Jan-21, Volume: 5, Issue:1

    Topics: Acute Kidney Injury; Age Factors; Aged; Aged, 80 and over; Databases, Factual; Drug Prescriptions; D

2016
Mineralocorticoid Receptor Blockade for Prevention of Acute Kidney Injury: An Elusive Target.
    American journal of kidney diseases : the official journal of the National Kidney Foundation, 2017, Volume: 69, Issue:2

    Topics: Acute Kidney Injury; Aldosterone; Humans; Kidney; Mineralocorticoid Receptor Antagonists; Receptors,

2017
Exposure of the elderly to potential nephrotoxic drug combinations in Belgium.
    Pharmacoepidemiology and drug safety, 2008, Volume: 17, Issue:10

    Topics: Acute Kidney Injury; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Angiotensin-C

2008
Spironolactone use and renal toxicity: population based longitudinal analysis.
    BMJ (Clinical research ed.), 2010, May-18, Volume: 340

    Topics: Acute Kidney Injury; Aged; Angiotensin-Converting Enzyme Inhibitors; Creatine; Female; Heart Failure

2010
[An elderly man with known heart failure admitted with cardiogenic shock].
    Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 2010, Jul-01, Volume: 130, Issue:13

    Topics: Acute Kidney Injury; Adrenergic beta-Antagonists; Aged; Angiotensin II Type 1 Receptor Blockers; Ang

2010
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
    EMBO molecular medicine, 2011, Volume: 3, Issue:1

    Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular

2011
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
    EMBO molecular medicine, 2011, Volume: 3, Issue:1

    Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular

2011
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
    EMBO molecular medicine, 2011, Volume: 3, Issue:1

    Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular

2011
Hsp72 is an early and sensitive biomarker to detect acute kidney injury.
    EMBO molecular medicine, 2011, Volume: 3, Issue:1

    Topics: Acute Kidney Injury; Acute-Phase Proteins; Animals; Biomarkers; Creatine; Hepatitis A Virus Cellular

2011
Mineralocorticoid receptor activation: a major contributor to salt-induced renal injury and hypertension in young rats.
    American journal of physiology. Renal physiology, 2011, Volume: 300, Issue:6

    Topics: Acute Kidney Injury; Aldosterone; Analysis of Variance; Angiotensin II Type 1 Receptor Blockers; Ani

2011
Long-term effects of aldosterone blockade in resistant hypertension associated with chronic kidney disease.
    Journal of human hypertension, 2012, Volume: 26, Issue:8

    Topics: Acute Kidney Injury; Aged; Alabama; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting

2012
Angiotensin II- and salt-induced kidney injury through Rac1-mediated mineralocorticoid receptor activation.
    Journal of the American Society of Nephrology : JASN, 2012, Volume: 23, Issue:6

    Topics: Acute Kidney Injury; Adrenalectomy; Aldosterone; Analysis of Variance; Angiotensin II; Animals; Blot

2012
Recovery from ischemic acute kidney injury by spironolactone administration.
    Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2012, Volume: 27, Issue:8

    Topics: Acute Kidney Injury; Aldosterone; Animals; Drug Administration Schedule; HSP72 Heat-Shock Proteins;

2012
Life-threatening hyperkalemia--an overlooked acute kidney injury with a serum creatinine rise in the 'normal' range.
    BMJ case reports, 2012, May-08, Volume: 2012

    Topics: Acute Kidney Injury; Aged; Creatinine; Diuretics; Electrocardiography; Female; Humans; Hyperkalemia;

2012
Obesity and oxidative stress predict AKI after cardiac surgery.
    Journal of the American Society of Nephrology : JASN, 2012, Volume: 23, Issue:7

    Topics: Acute Kidney Injury; Aged; Angiotensin-Converting Enzyme Inhibitors; Biomarkers; Body Mass Index; Ca

2012
Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury.
    Kidney international, 2013, Volume: 83, Issue:1

    Topics: Acute Kidney Injury; Animals; Collagen Type I; Disease Models, Animal; Diuretics; Dose-Response Rela

2013
Spironolactone rescues Dot1a-Af9-mediated repression of endothelin-1 and improves kidney injury in streptozotocin-induced diabetic rats.
    PloS one, 2012, Volume: 7, Issue:10

    Topics: Acute Kidney Injury; Aldosterone; Animals; Diabetes Mellitus, Experimental; Diabetic Nephropathies;

2012
Interaction of spironolactone with ACE inhibitors or angiotensin receptor blockers: analysis of 44 cases.
    BMJ (Clinical research ed.), 2003, Jul-19, Volume: 327, Issue:7407

    Topics: Acute Kidney Injury; Aged; Angiotensin Receptor Antagonists; Antihypertensive Agents; Diuretics; Dru

2003
Normal ECG or peaked T waves?
    Hospital practice (1995), 1998, May-15, Volume: 33, Issue:5

    Topics: Acute Kidney Injury; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Diabetes Mell

1998
Diuretic agents. Mechanisms of action and clinical uses.
    Postgraduate medicine, 1976, Volume: 59, Issue:4

    Topics: Acute Kidney Injury; Benzothiadiazines; Carbonic Anhydrase Inhibitors; Diabetes Insipidus; Diuretics

1976
[Severe complications during enalapril therapy for heart insufficiency].
    Schweizerische medizinische Wochenschrift, 1988, Dec-03, Volume: 118, Issue:48

    Topics: Acute Kidney Injury; Drug Interactions; Enalapril; Heart Failure; Humans; Hypotension; Male; Middle

1988
[Acute reversible kidney insufficiency due to enalapril during diuretic-treated heart insufficiency].
    Deutsche medizinische Wochenschrift (1946), 1987, Jun-12, Volume: 112, Issue:24

    Topics: Acute Kidney Injury; Adult; Drug Therapy, Combination; Enalapril; Female; Heart Failure; Humans; Hyp

1987
[Disorders of water-electrolyte metabolism associated with decompensated cirrhosis. The danger of various therapeutic drugs].
    La semaine des hopitaux : organe fonde par l'Association d'enseignement medical des hopitaux de Paris, 1968, May-14, Volume: 44, Issue:23

    Topics: Acute Kidney Injury; Adult; Aged; Ascites; Blood Transfusion; Blood Urea Nitrogen; Blood Volume Dete

1968
[Hyperkalemias in cardiac patients].
    La semaine des hopitaux : organe fonde par l'Association d'enseignement medical des hopitaux de Paris, 1974, Oct-08, Volume: 50, Issue:40

    Topics: Acidosis; Acute Kidney Injury; Adult; Aged; Arrhythmias, Cardiac; Digitalis Glycosides; Diuretics; F

1974
[New aspects of the use of spironolactone and its association with thiabutazide (per os and in injections) in the treatment of grave cardiac insufficiency].
    Medicina interna, 1974, Volume: 26, Issue:2

    Topics: Acute Kidney Injury; Administration, Oral; Adult; Aged; Benzothiadiazines; Diabetes Complications; D

1974
Mercury poisoning: prevention by spironolactone.
    Science (New York, N.Y.), 1970, Aug-21, Volume: 169, Issue:3947

    Topics: Acute Kidney Injury; Animals; Chelating Agents; Dimercaprol; Female; Kidney Tubules; Mercury Poisoni

1970
Renal failure with cirrhosis. Observations on the role of diuretics.
    Annals of internal medicine, 1966, Volume: 64, Issue:6

    Topics: Acute Kidney Injury; Aminohippuric Acids; Ascites; Blood; Blood Volume; Creatine; Diuretics; Ethacry

1966