Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal saline. The volume of fluid given in each arm of the study is equal. All other interventions in those patients will be according to standard cardiothoracic anesthesia protocol at our institution.

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

Details

• Lead Sponsor: Wake Forest University Health Sciences

Criteria

Inclusion Criteria:

• Calculated GFR ≤ 60 ml/min/m2 (MDRD)

OR

• Any combination of two (2) of the following:

• Age ≥ 70

• Complex surgery (any of the following):

• CABG/Valve

• Redo operation

• Deep hypothermic arrest

• ≥ 2 valves

• History of PVD surgery

• EF < 35%

• Presence of diabetes mellitus

• Prior kidney transplant

Exclusion Criteria:

• Age < 18

• Pre-existing ESRD (dialysis patients)

• Pre-op GFR ≤ 15 ml/min/m2

• Pre-op bicarbonate level ≥ 30 mEq/L

• Emergency surgery (unable to effectively consent)

• Pregnancy

• Heart transplant (OHT)

• Aortic surgery (proximal or distal)