Prevention of Acute Kidney Injury in Cardiac Surgery Patients

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Community Medical Center, Scranton, PA
• Treatments: Polystyrene sulfonic acid

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