A Study of The Effectiveness of N-Acetylcysteine in Kidney Protection Following Cardiopulmonary Bypass
Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
Summary
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.