Overview

Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate Therapy

Status:
Unknown status
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether sodium bicarbonate is effective in reducing kidney injury that may occur during cardiac surgery.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
McGill University Health Center
McGill University Health Centre/Research Institute of the McGill University Health Centre
Criteria
Inclusion criteria:

- age greater than or equal to 18 years

- elective or urgent CABG +/- valve surgery, or elective or urgent isolated valve
surgery

- exposure to cardiopulmonary bypass

- stable kidney disease: less than 25% change in serum creatinine during 3 months before
surgery

- Estimated glomerular filtration rate, by Modification of Diet in Renal Disease (MDRD)
equation, less than or equal to 60 ml/min/1.73m2

Exclusion criteria:

- emergency CABG, cardiac transplantation, or insertion of VAD

- planned off-pump surgery

- N-acetylcysteine given in last 72 hours prior to operation

- radiocontrast given in last 48 hours prior to operation

- acute renal failure (greater than 25% increase in serum creatinine from preadmission
baseline)

- glomerular filtration rate less than 15 ml/min or chronic dialysis

- prior renal transplantation

- enrollment in another research study, with the exception of MUHC study SDR-05-033

- LV ejection fraction less than or equal to 20%