Overview
Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate Therapy
Status:
Unknown status
Unknown status
Trial end date:
2013-03-01
2013-03-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
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%