Abstract 15095: Preventing Acute Renal Failure after Cardiac Surgery in High Risk Patients using Sodium Bicarbonate Therapy (PARACHUTE): Interim Analysis of a Double-Blind Randomized Controlled Study
Introduction: Acute kidney injury (AKI) following cardiac surgery is associated with significant postoperative morbidity and mortality. Preoperative renal protective approaches are needed to prevent postoperative AKI, and may improve patient outcome. The use of sodium bicarbonate for prophylaxis against AKI in high risk patients undergoing cardiac surgery has not been previously described.
Hypothesis: We hypothesized that preoperative alkalinization with sodium bicarbonate is more effective than sodium chloride in the prevention of AKI in high risk patients undergoing cardiac surgery.
Methods: A double-blind, randomized controlled study enrolling patients with stable chronic kidney disease (estimated GFR 15–60 mL/min/1.73 m2) undergoing non-emergency cardiac surgery using cardiopulmonary bypass. The study will randomize 200 patients to receive either sodium bicarbonate (150 mEq Na/L) or sodium chloride (154 mEq Na/L) intravenously at 1 mL/kg/hour for 6 hours prior to cardiopulmonary bypass. The primary outcome is postoperative AKI (increase in serum creatinine > 25% or 44 μmol/L). Secondary outcomes include in-hospital mortality, postoperative length of hospitalization, dialysis, inotrope use, respiratory failure, reoperation, myocardial infarction, stroke, sepsis, pneumonia, and electrolyte abnormalities.
Results: We present the results of the first 110 patients randomized — 55 in each treatment arm. There were no significant group differences in baseline patient characteristics including age, gender, diabetes mellitus, congestive heart failure, Parsonnet score, or type of surgery. Preoperative GFR was 42.3 ± 9.8 and 43.2 ± 11.4 mL/min/1.73 m2 (p=0.68) in patients receiving sodium chloride and sodium bicarbonate, respectively. Postoperative AKI occurred in 26 patients (47%) in both groups. No significant differences were observed in secondary outcomes, and there were no adverse events associated with sodium bicarbonate administration as compared to sodium chloride.
Conclusions: Preoperative hydration with sodium bicarbonate, as compared to sodium chloride, may not offer additional protection against AKI in high risk patients undergoing cardiac surgery. ClinicalTrials.Gov Identifier NCT00522756
- © 2010 by American Heart Association, Inc.