Phase 2
Completed N=92
Prevention of Acute Kidney Injury in Cardiac Surgery Patients
Source: ClinicalTrials.gov NCT00921518 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Number of Participants With Acute Kidney Injury — 20; 14 participants
Summary
Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients following cardiac surgery, and at least 50% of patients with underlying renal insufficiency. Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of developing post-operative AKI. The purpose of the current study is to determine if intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is effective at preventing post-operative AKI in patients with baseline kidney insufficiency and who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Kidney Injury |
20; 14 | — |
Eligibility Criteria
Inclusion Criteria
- elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass
- baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation
Exclusion Criteria
- cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump)
- end-stage kidney disease requiring dialysis
- received an infusion of sodium bicarbonate on the same day as cardiac surgery
Data sourced from ClinicalTrials.gov (NCT00921518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.