An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)
|ClinicalTrials.gov Identifier: NCT00530361|
Recruitment Status : Withdrawn (Study was withdrawn prior to patient dosing based on a business decision.)
First Posted : September 17, 2007
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Surgery Coronary Heart Disease Coronary Artery Bypass Grafting Cardiopulmonary Bypass Ischemic Heart Disease Heart Failure, Congestive||Drug: Nesiritide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Study of Nesiritide Administered After Induction of Anesthesia in Heart Failure Patients With Renal Insufficiency Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (NAPA-CS)|
|Estimated Study Completion Date :||September 2009|
- The composite of a 25% decrease in postoperative glomerular filtration rate, occurrence of postoperative dialysis, and all-cause mortality through Day 30; The composite of occurrence of postoperative dialysis and all-cause mortality through Day 90.
- The occurrence of new-onset postoperative atrial fibrillation through 96 hours after randomization. The composite of re-intubation for respiratory failure and all-cause mortality through 30 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530361
|Study Director:||Scios, Inc. Clinical Trial||Scios, Inc.|