Nesiritide Use Following Cardiac Surgery in Infants
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|ClinicalTrials.gov Identifier: NCT00281671|
Recruitment Status : Terminated (Slow patient enrollment.)
First Posted : January 25, 2006
Last Update Posted : January 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Heart Defects, Congenital Cardiopulmonary Bypass||Drug: nesiritide||Phase 1 Phase 2|
Nesiritide, a recombinant human B-type natriuretic peptide, has vasodilatory, lusitropic and diuretic properties in healthy humans, and improves hemodynamics and symptoms in adults with decompensated congestive heart failure. Several retrospective case series suggest that nesiritide has beneficial effects on hemodynamics and urine output in adults and children following cardiac surgery.
The purpose of this prospective, randomized, double-blind, crossover study is to evaluate the effects of a continuous infusion of nesiritide on postoperative hemodynamics and urine output in infants with congenital heart disease who undergo cardiac surgery requiring cardiopulmonary bypass (CPB). Patients less than 1 year of age following cardiac surgery will be eligible for the study if they have received two conventional diuretics (furosemide and chlorothiazide) for at least 12 hours, yet are not effectively achieving a negative fluid balance, thus prohibiting sternal closure or tracheal extubation. Patients will be randomized to receive either a 10-hour infusion of nesiritide, a two hour washout period, followed by a 10-hour infusion of placebo, or this study drug sequence in reverse order. During the 24-hour study period, serial cardiac output measurements and BNP levels will be obtained, vital signs and intracardiac filling pressures will be recorded, and urine output will be measured.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study of the Effects of Nesiritide on Hemodynamics and Urine Output Following Cardiopulmonary Bypass in Infants|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.
nesiritide 0.015 mcg/kg/hour x 10 hours
Other Name: Natrecor
- urine output [ Time Frame: 5 hours ]
- Safety [ Time Frame: 48 hours ]
- urine output [ Time Frame: 10 hours ]
- cardiac index [ Time Frame: 6 horus ]
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): NCT00281671
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||John M Costello, MD||Department of Cardiology, Children's Hospital Boston|