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)
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|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Recruitment Status : Withdrawn (Study was withdrawn prior to patient dosing based on a business decision.)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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530361
|Study Director:||Scios, Inc. Clinical Trial||Scios, Inc.|