sodium-acetate--anhydrous and Critical-Illness

Whether the use of balanced multielectrolyte solution (BMES) in preference to 0.9% sodium chloride solution (saline) in critically ill patients reduces the risk of acute kidney injury or death is uncertain.. In a double-blind, randomized, controlled trial, we assigned critically ill patients to receive BMES (Plasma-Lyte 148) or saline as fluid therapy in the intensive care unit (ICU) for 90 days. The primary outcome was death from any cause within 90 days after randomization. Secondary outcomes were receipt of new renal-replacement therapy and the maximum increase in the creatinine level during ICU stay.. A total of 5037 patients were recruited from 53 ICUs in Australia and New Zealand - 2515 patients were assigned to the BMES group and 2522 to the saline group. Death within 90 days after randomization occurred in 530 of 2433 patients (21.8%) in the BMES group and in 530 of 2413 patients (22.0%) in the saline group, for a difference of -0.15 percentage points (95% confidence interval [CI], -3.60 to 3.30; P = 0.90). New renal-replacement therapy was initiated in 306 of 2403 patients (12.7%) in the BMES group and in 310 of 2394 patients (12.9%) in the saline group, for a difference of -0.20 percentage points (95% CI, -2.96 to 2.56). The mean (±SD) maximum increase in serum creatinine level was 0.41±1.06 mg per deciliter (36.6±94.0 μmol per liter) in the BMES group and 0.41±1.02 mg per deciliter (36.1±90.0 μmol per liter) in the saline group, for a difference of 0.01 mg per deciliter (95% CI, -0.05 to 0.06) (0.5 μmol per liter [95% CI, -4.7 to 5.7]). The number of adverse and serious adverse events did not differ meaningfully between the groups.. We found no evidence that the risk of death or acute kidney injury among critically ill adults in the ICU was lower with the use of BMES than with saline. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; PLUS ClinicalTrials.gov number, NCT02721654.).

Topics: Acute Kidney Injury; Adult; Aged; Critical Care; Critical Illness; Double-Blind Method; Female; Fluid Therapy; Gluconates; Humans; Intensive Care Units; Magnesium Chloride; Male; Middle Aged; Potassium Chloride; Saline Solution; Sodium Acetate; Sodium Chloride; Treatment Outcome

The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown.. To test the hypothesis that a balanced crystalloid solution, compared with saline, decreases 90-day all-cause mortality among critically ill patients; and to test the hypothesis that slow, compared with rapid, infusion rate decreases 90-day mortality in this population of patients.. The Balanced Solution versus Saline in Intensive Care Study (BaSICS) is a pragmatic, 2 ??2 factorial, randomised controlled trial. A total of 11 000 patients will be recruited from at least 100 Brazilian intensive care units. Patients will be randomised to receive Plasma-Lyte 148 or saline, and to rapid infusion (999 mL/h) or slow infusion (333 mL/h). Study fluids will be used for resuscitation episodes (at rapid or slow infusion rates), dilution of compatible medications and maintenance solutions. Patients, health care providers and investigators will be blinded to the solutions being tested. The rate of bolus infusion will not be blinded.. The primary outcome is 90-day all-cause mortality. Secondary outcomes are: incidence of renal failure requiring renal replacement therapy within 90 days, incidence of acute kidney injury (Kidney Disease: Improving Global Outcomes stages 2 and 3), incidence of non-renal organ dysfunction assessed by Sepsis-related Organ Failure Assessment score at Days 3 and 7, and number of mechanical ventilationfree days within the first 28 days after randomisation.. The BaSICS trial will provide robust evidence on whether a balanced crystalloid, compared with saline, improves important patient outcomes in critically ill patients. BaSICS will also provide relevant information on whether bolus infusion rate affects outcomes in this population.. ClinicalTrials.gov NCT02875873.

Topics: Aged; Brazil; Cause of Death; Critical Illness; Double-Blind Method; Fluid Therapy; Gluconates; Hospital Mortality; Humans; Infusions, Intravenous; Intensive Care Units; Magnesium Chloride; Patient Selection; Potassium Chloride; Research Design; Sodium Acetate; Sodium Chloride

0.9% sodium chloride (saline) is the most commonly administered resuscitation fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects.. To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for fluid therapy results in different 90-day all-cause mortality when compared with saline.. We will conduct this multicentre, blinded, randomised controlled trial in approximately 50 intensive care units in Australia and New Zealand. We will randomly assign 8800 patients to either Plasma-Lyte 148 or saline for all resuscitation fluid, maintenance fluid and compatible drug dilution therapy while in the ICU for up to 90 days after randomisation.. The primary outcome is 90-day all-cause mortality; secondary outcomes include mean and peak creatinine concentration, incidence of renal replacement therapy, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, ICU and hospital length of stay, and quality of life and health services use at 6 months.. The PLUS study will provide high-quality data on the comparative safety and efficacy of Plasma-Lyte 148 compared with saline for resuscitation and compatible crystalloid fluid therapy in critically ill adult patients.

Topics: Australia; Creatinine; Critical Illness; Fluid Therapy; Gluconates; Health Services; Humans; Intensive Care Units; Length of Stay; Magnesium Chloride; Mortality; New Zealand; Potassium Chloride; Quality of Life; Renal Replacement Therapy; Respiration, Artificial; Resuscitation; Sodium Acetate; Sodium Chloride; Time Factors; Vasoconstrictor Agents; Vasodilator Agents

Normal saline (NS) is the most commonly used crystalloid solution worldwide but contains an excess of chloride and may cause metabolic acidosis and hyperchloraemia. Such abnormalities may be attenuated by the use of a balanced solution such as Plasma-Lyte 148 (PL-148).. To assess the feasibility, safety and biochemical and physiological effects of resuscitation with NS versus PL-148 in critically ill patients.. An exploratory, multicentre, doubleblind, randomised controlled trial involving patients aged ≥ 18 years who were prescribed crystalloid fluid resuscitation by the treating clinician between 16 July and 22 October 2015, in three multidisciplinary intensive care units in Melbourne, Victoria, Australia.. Random allocation of NS or PL-148 was concealed, and all fluids were delivered in indistinguishable bags.. NS or PL-148 was administered for all fluid resuscitation and for all subsequent crystalloid fluid therapy until Day 4 of ICU admission. The treating intensivist determined the rate and frequency of fluid administration.. Primary outcome was daily base excess (BE). Relevant secondary outcomes included the incidence of acute kidney injury (AKI), change in serum creatinine and serum chloride levels, and mortality.. Seventy patients were recruited, with 34 in the NS group and 33 in the PL-148 group available for analysis. Baseline characteristics of study patients were well balanced; the mean ages were 64 and 62 years, respectively, and nearly two-thirds of the patients in each group were men. The median Acute Physiology and Chronic Health Evaluation III scores were 64 for the NS group (interquartile range [IQR], 48-73) and 55 for the PL-148 group (IQR, 44-81). After treatment, there was no significant difference in the worst (most negative) median BE between the NS and PL-148 groups (-4 mEq/L [IQR, -7 to -2 mEq/L] v -3 mEq/L [IQR, -7 to 2 mEq/L]; P = 0.42). Chloride levels were significantly higher with NS therapy (median, 111 mmol/L [IQR, 108-116 mmol/L] v 108 mmol/L [IQR, 106-110 mmol/L]; P = 0.01). There was no significant difference in the incidence of AKI (P = 0.48), peak creatinine levels (P = 0.92) or ICU or hospital mortality between the two groups.. In our exploratory, double-blind, randomised controlled trial, when compared with NS, PL-148 did not significantly increase BE values in critically ill patients requiring fluid resuscitation, but decreased peak chloride concentrations.

Topics: Aged; Australia; Critical Care; Critical Illness; Crystalloid Solutions; Double-Blind Method; Feasibility Studies; Female; Fluid Therapy; Gluconates; Humans; Isotonic Solutions; Magnesium Chloride; Male; Middle Aged; Pilot Projects; Potassium Chloride; Sodium Acetate; Sodium Chloride; Treatment Outcome

The prupose was to identify, through the BreathID automatic breath-testing device, the best prokinetic therapy to enhance gastric-emptying rate (GER) in ventilated intensive care unit patients.. This was a prospective, crossover, nonrandomized study. Consecutive ventilated patients who could be fed enterally and expected to require 5 days of ventilation were included. (13)C-labeled-acetate in 100 mL Osmolite (BreathID; Exalenz Bioscience Ltd, Jerusalem, Israel) was administered intragastrically and followed by a 4-hour continuous recording of expiratory (13)CO2 by the BreathID. Prokinetics were changed daily: (1) baseline (no prokinetic), (2) intravenous (IV) metoclopramide (10 mg every 6 hours), (3) IV metoclopramide (10 mg every 6 hours) and continuous low-dose erythromycin (10 mg/h), (4) IV continuous low-dose erythromycin alone (10 mg/h), and (5) IV bolus erythromycin (200 mg every 12 hours). Gastric-emptying rate was assessed by the percentage dose recovered (PDR)-change from time 0 of the recording in the ratio of (13)CO2/(12)CO2 in exhaled gases (%/h). We used PDR peak values and time to peak (minutes to reach PDR peak) to express GER.. In the first 17 patients (group A), baseline GER measurements preceded prokinetic therapy. In the subsequent 14 patients (group B), 2 prokinetic regimens preceded baseline. No order-time effect was observed, justifying pooled analysis of all 31 patients. Combined metoclopramide-continuous low-dose erythromycin yielded significantly higher PDR peak and shorter time to peak vs baseline (P = .0001, P = .005, respectively). The PDR peak was also significantly higher from baseline during continuous low-dose administration of erythromycin alone (P = .004). Metoclopramide alone did not improve GER significantly.. Combined metoclopramide-continuous low-dose erythromycin was found to be the best protocol in the current study to increase GER in ventilated patients. It should be tested as a first-line prokinetic therapy in ventilated patients with poor gastric emptying in further randomized controlled studies. The breath-test device presented in this study can be a user-friendly and practical method to monitor GER, enabling individual tailoring of prokinetic therapy. Further studies to explore its utility are warranted.

Topics: Adult; Aged; Aged, 80 and over; Breath Tests; Carbon Isotopes; Critical Care; Critical Illness; Cross-Over Studies; Enteral Nutrition; Erythromycin; Female; Gastric Emptying; Gastrointestinal Agents; Humans; Israel; Male; Metoclopramide; Middle Aged; Prospective Studies; Respiration, Artificial; Sodium Acetate

Topics: Clinical Protocols; Critical Illness; Fluid Therapy; Gluconates; Humans; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride

Sodium acetate has been shown to cause hemodynamic instability when used as a hemodialysis buffer. The pattern of hemodynamic response to injury will be evaluated between those who received sodium acetate and those who did not.The primary purpose of the study is to analyze the effect of sodium acetate on hemodynamic parameters. Secondarily we looked at the effects on prevention and treatment of hyperchloremic metabolic acidosis.. The study arm was comprised of patients who had received sodium acetate infusions in place of normal saline between March 2005 and December 2009. A control arm was created based on matching three pre-treatment variables: injury severity score (ISS), pH (+/- 0.03) and base deficit (+/- 3). A retrospective chart review was performed for patients in both arms. Blood pressure, arterial blood gas data and chemistry values were recorded for the time points of -6, -1, 0, 1, 6, 12, 24, 48, and 72 hours from start of sodium acetate infusion. Patients were excluded based on the following criteria: patients who were given sodium bicarbonate within 48 hours of starting sodium acetate, those given sodium acetate as a bolus, non-trauma patients, burn patients, patients who expired within 24 hours of arrival to the ICU, patients diagnosed with rhabdomyolysis and patients whose medical record could not be obtained.. A total of 78 patients were included in the study, 39 in the study arm and 39 in the control arm. There were no statistically significant drops in blood pressure within either group. The median pH between the two groups at the start of infusion was equal. Both groups trended towards normal pH with the study arm improving faster than the control arm. The median serum bicarbonate at start of sodium acetate infusion was 19 mmol/L and 20 mmol/L at time zero for the study and control arms respectively with both trending upward during the study period. Chloride trended up initially in both groups but the study arm began to correct sooner at 24 hours compared to 48 hours for the control arm.. We analyzed the use of sodium acetate as an alternative to normal saline or lactated ringers during resuscitation of critically ill trauma patients at a single center. Our data shows that the hemodynamic profile remained favorable, without evidence of instability at any point during the study period. Normalization of hyperchloremia and metabolic acidosis occurred faster in the patients who received sodium acetate.

Topics: Acid-Base Equilibrium; Acidosis; Adolescent; Adult; Aged; Aged, 80 and over; Critical Illness; Female; Hemodynamics; Humans; Male; Medical Audit; Middle Aged; Retrospective Studies; Sodium Acetate; Young Adult