Status:
COMPLETED
A Study of The Effectiveness of N-Acetylcysteine in Kidney Protection Following Cardiopulmonary Bypass
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Heart Disease
Renal Insufficiency
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Background: N-acetylcysteine (NAC) is an oral or intravenous agent that replenishes glutathione which in turn allows for the formation of glutathione peroxidase, an important enzyme in the degradatio...
Eligibility Criteria
Inclusion
- The study includes those patients with preoperative renal dysfunction (serum creatinine level 140 μmol/L or greater or a calculated glomerular filtration rate of 50 mL/min or less), or a risk factor score for postoperative renal dysfunction that adds up to 6 or more based on the following scale:
- Score Risk Factor:
- 3 scheduled for redo cardiac surgery
- 3 scheduled for valve surgery
- 2 age greater than 69 at time of surgery
- 2 known diabetic (Type I or II)
- 2 congestive heart failure
- 2 treated hypertension
- 2 chronic obstructive pulmonary disease
- 2 preoperative stroke
- 1 left ventricular function -grade 3 or 4 (seen on echo or angiogram)
- 1 New York Heart Association Class 3 or 4
Exclusion
- Patient is participating in another trial
- Patient has received NAC in the past 48 hours.
- Patient has allergy to N-acetylcysteine.
- Patient scheduled for off-pump surgery or an extracardiac procedure (pericardiectomy etc.)
- Patient requires emergent surgery
- Patient scheduled for a procedure involving circulatory arrest.
- Patient requires chronic dialysis (peritoneal or hemodialysis)
- Patient unable to give informed consent (dementia, does not speak English, etc.)
- Patient has a recent history of cancer (in last five years) or untreated cancer
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00187330
Start Date
March 1 2004
End Date
August 1 2005
Last Update
September 16 2005
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