Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122018
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2005-07-14
Brief Title:
An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery
Sponsor:
Linda F Barr MD
Organization:
Pulmonary Critical Care Associates of Baltimore
Study Overview
Official Title:
N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2014-11
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:
Patients with abnormal kidney function are at increased risk for complications following heart surgery including worsening kidney function possibly requiring dialysis a prolonged stay in the critical care unit and hospital and the increased risk of death Prior attempts at kidney protection for heart surgery patients have had mixed results Two medicines fenoldopam and N-acetylcysteine have been shown to protect kidney function in other circumstances that cause kidney stress The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery
Detailed Description:
This is a randomized double-blinded placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine NAC individually and together as renal protective agents for patients with renal insufficiency undergoing heart surgery Subjects have chronic renal insufficiency with creatinine clearance CrCl 40ccmin but not on pre-operative dialysis and receive NAC 600 mg by mouth po twice a day bid or placebo starting 24 hours pre-operative and continuing through the day of surgery andor fenoldopam 01 mcgkgmin intravenous IV or saline placebo at anesthetic induction and continuing for 48 hours Outcome data include nadir post-operative day 3 and post-operative day 14 CrCl time to CrCl nadir length of Intensive Care Unit ICU stay length of post-operative hospital stay hospital costs mortality and the need for hemodialysis Intraoperative and post-operative pressor use is being monitored The enrollment will include 80 patients 20 in each group
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