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Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre The Physicians' Services Incorporated Foundation |
Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00187330 |
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.
Condition | Intervention | Phase |
Heart Disease Renal Insufficiency |
Drug: Intravenous N-acetylcysteine |
Phase II |
MedlinePlus related topics: | Heart Diseases |
Drug Information available for: | Acetylcysteine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 104 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | August 2005 |
Show Detailed Description |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Score Risk Factor:
Exclusion Criteria:
Sunnybrook Health Sciences Centre |
The Physicians' Services Incorporated Foundation |
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 |
Study ID Numbers: | 724180589, R03-45, www.psifoundation.org |
First Received: | September 9, 2005 |
Last Updated: | September 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00187330 |
Health Authority: | Canada: Health Canada |
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