labetalol and Renal Insufficiency studies

Labetalol: A salicylamide derivative that is a non-cardioselective blocker of BETA-ADRENERGIC RECEPTORS and ALPHA-1 ADRENERGIC RECEPTORS.
labetalol : A diastereoisomeric mixture of approximately equal amounts of all four possible stereoisomers ((R,S)-labetolol, (S,R)-labetolol, (S,S)-labetalol and (R,R)-labetalol). It is an adrenergic antagonist used to treat high blood pressure.
2-hydroxy-5-{1-hydroxy-2-[(4-phenylbutan-2-yl)amino]ethyl}benzamide : A member of the class of benzamides that is benzamide substituted by a hydroxy group at position 2 and by a 1-hydroxy-2-[(4-phenylbutan-2-yl)amino]ethyl group at position 5.

Renal Insufficiency: Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE.

Research Excerpts

Excerpt	Relevance	Reference
" Food and Drug Administration (FDA)-recommended doses of labetalol and nicardipine for hypertension (HTN) management in a subset of patients with renal dysfunction (RD)."	9.19	The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine? ( Baumann, BM; Borczuk, P; Cannon, CM; Chandra, A; Cline, DM; Diercks, DB; Hiestand, B; Hsu, A; Jois-Bilowich, P; Kaminski, B; Levy, P; Nowak, RM; Peacock, WF; Schrock, JW; Soto-Ruiz, KM; Varon, J, 2014)
" Food and Drug Administration (FDA)-recommended doses of labetalol and nicardipine for hypertension (HTN) management in a subset of patients with renal dysfunction (RD)."	5.19	The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine? ( Baumann, BM; Borczuk, P; Cannon, CM; Chandra, A; Cline, DM; Diercks, DB; Hiestand, B; Hsu, A; Jois-Bilowich, P; Kaminski, B; Levy, P; Nowak, RM; Peacock, WF; Schrock, JW; Soto-Ruiz, KM; Varon, J, 2014)

Research

Studies (1)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Average Number of Dose Titrations Within 30 Minutes

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Varon, J	1
Soto-Ruiz, KM	1
Baumann, BM	1
Borczuk, P	1
Cannon, CM	1
Chandra, A	1
Cline, DM	1
Diercks, DB	1
Hiestand, B	1
Hsu, A	1
Jois-Bilowich, P	1
Kaminski, B	1
Levy, P	1
Nowak, RM	1
Schrock, JW	1
Peacock, WF	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase IV, Randomized Trial to Determine the Efficacy and Safety of Cardene Intravenous (I.V.) Versus Labetalol for Management of Hypertensive Emergencies in the Emergency Department Setting[NCT00765648]	Phase 4	226 participants (Actual)	Interventional	2008-10-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group (NCT00765648)
Timeframe: 30 minutes

Emergency Department(ED)Time to Disposition Decision

Intervention	number of titrations (Mean)
Nicardipine	2.2
Labetalol	1.3

Median number of hours from hospital admission until Emergency Department(ED)disposition (NCT00765648)
Timeframe: 6 hours

Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.

Intervention	hours (Median)
Nicardipine	4.6
Labetalol	4.6

Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator. (NCT00765648)
Timeframe: 30 minutes after initiation of therapy

Subjects Requiring the Use of Intravenous Rescue Medications

Intervention	percentage of participants (Number)
Nicardipine	91.7
Labetalol	82.5

The percent of subjects requiring the use of intravenous rescue medications (NCT00765648)
Timeframe: 6 hours

Transition Time to Oral Medication

Intervention	percentage of participants (Number)
Nicardipine	15.5
Labetalol	22.4

The median transition time (in hours) to oral medication (NCT00765648)
Timeframe: 6 hours

Treatment Failure

Intervention	hours (Median)
Nicardipine	4.9
Labetalol	6.4

Treatment failure is defined as admission to the hospital or observation unit for BP management (NCT00765648)
Timeframe: 6 hours