Prevention of Acute Kidney Injury in Cardiac Surgery Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Kidney Injury
In brief
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.
Key facts
- Study ID
- NCT00921518
- Run by
- Community Medical Center, Scranton, PA
- People needed
- 92
- Starts
- 2009-01-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2014-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Community Medical Center — Scranton, Pennsylvania, United States
Full record on ClinicalTrials.gov
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