A Study of The Effectiveness of N-Acetylcysteine in Kidney Protection Following Cardiopulmonary Bypass
N-acetylcysteine is a medication that has most commonly been used in the past to prevent liver damage after an acetaminophen overdose. N-acetylcysteine has also been used in patients with pre-existing kidney damage to prevent further kidney damage resulting from dye that is used in tests such as angiograms (dye studies). This study hopes to prove that this medication may also help to protect kidneys from the damage caused by the heart-lung machine during cardiac surgery. This damage to the kidneys happens to patients undergoing cardiac surgery requiring the use of the heart-lung machine. Kidney failure after surgery is a serious complication (2-30% of patients with kidney problems can develop it) and it can lead to short term and long-term dialysis as well as death (there is up to a 30% death rate once kidney failure develops). The study will test if intravenous N-acetylcysteine is safe and effective in preventing kidney problems after cardiac surgery using the heart-lung machine. Approximately 104 patients will be enrolled at Sunnybrook and Women’s College Health Science Centre. The study has been reviewed and approved by the ethics committee at Sunnybrook and Women’s College Health Science Centre. The study will compare the effects of N-acetylcysteine with those of placebo (salt solution). The study medication (either N-acetylcysteine or placebo) will be given in addition to your usual medication and surgical procedures.
Drug: Intravenous N-acetylcysteine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|Official Title:||A Randomized Placebo Controlled Trial of Intravenous N-Acetylcysteine (NAC) As A Renal Protective Agent for Prevention of Renal Dysfunction Following Cardiopulmonary Bypass (CPB)|
- The change in serum creatinine between NAC and placebo groups from preoperative baseline levels to peak postoperative levels after exposure to CPB.
- Include change in GFR, BUN and troponin; early dialysis; in-hospital mortality; postop MI; stroke; and postop LOS. SNPs related to renal insufficiency, ischemia, and inflammation will be analyzed in relation to serum inflammatory markers.
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||August 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187330
|Principal Investigator:||Veena Guru, MD||University of Toronto, Sunnybrook and Women's College Health Sciences Centre|
|Study Chair:||Stephen E Fremes, MD||Sunnybrook Health Sciences Centre|