Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281671
Status:
TERMINATED
Last Update Posted:
2020-08-27
First Post:
2006-01-23
Brief Title:
Nesiritide Use Following Cardiac Surgery in Infants
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Pilot Study of the Effects of Nesiritide on Hemodynamics and Urine Output Following Cardiopulmonary Bypass in Infants
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants Safety and pharmacokinetic data will also be obtained
Detailed Description:
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
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 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