Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188630
Status:
COMPLETED
Last Update Posted:
2011-04-20
First Post:
2005-09-09
Brief Title:
N-Acetylcysteine for Preventing Renal Injury After Cardiac Surgery
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
The PRIME Perioperative Renal Insufficiency Management Study A Randomized Double-blinded Placebo-controlled Trial of N-acetylcysteine for Preventing Renal Injury After Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiac surgery improves the survival and quality of life of people with heart disease Nonetheless several complications continue to adversely affect outcomes following cardiac surgery Kidney failure is a particularly important complication that is associated with increased death and duration of hospitalization The most severe form of postoperative kidney failure the need for dialysis is uncommon at present It is however likely to increase in the future Patients undergoing cardiac surgery are getting older with more heart failure diabetes high blood pressure and pre-existing kidney disease Given that these are risk factors for postoperative kidney injury dialysis rates will likely increase Although multiple therapies have been tested none have prevented postoperative kidney failure N-acetylcysteine NAC is a drug that is commonly used to treat Tylenol overdoses Over the past 2 years it has also been used to prevent kidney damage after exposure to IV dye There is good evidence that NAC will reduce kidney damage after IV dye exposure There are strong reasons to believe that NAC may also prevent postoperative kidney failure NAC is safe Its major side-effects are allergic reactions but serious reactions are rare Since dialysis is uncommon large studies are needed to determine if NAC prevents postoperative dialysis In this situation a pilot study is needed to determine if such a large trial is feasible This proposal describes a pilot study We will determine NACs effects on creatinine clearance a measure of how well the kidney works Reduced creatinine clearance is closely related to dialysis and death after cardiac surgery This biological marker allows us to determine NACs effects on kidney function with a reduced sample size If NAC improves creatinine clearance it would suggest that NAC prevents postoperative dialysis and would justify a larger study A pilot study will help us estimate how many patients will be willing to participate in similar studies vital for planning a future large study Finally our results will estimate how well NAC will reduce dialysis rates This is needed for calculating the sample size for future studiesThe study design is a randomized double-blinded placebo-controlled clinical trial among patients undergoing bypass surgery or heart valve surgery at the Toronto General Hospital Toronto ON We will recruit 176 people who are at increased risk for developing kidney failure after surgery Participants will receive either NAC or sugar solution during their operation If participants have returned home within a month of surgery they will be contacted at home on the 30th day after surgery to determine if they had any kidney-related problems since returning home All participants will return to the Toronto General Hospital TGH during the 8th week after surgery for creatinine blood test and weight
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSFO5231 | None | None | None |