Nesiritide Use Following Cardiac Surgery in Infants

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00281671
Study type	Interventional
Source	Boston Children's Hospital
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	April 8, 2006
Completion date	October 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04084301` - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury	N/A
Completed	`NCT04062396` - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction	N/A
Completed	`NCT02518087` - Increased Adsorption Membranes During Cardiopulmonary Bypass	N/A
Recruiting	`NCT01231776` - Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass	N/A
Completed	`NCT00747331` - Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass	Phase 4
Terminated	`NCT00176657` - The Use of HEMOBAG to Salvage Blood After Cardiac Surgery	Phase 2
Completed	`NCT00161733` - Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery	Phase 3
Completed	`NCT05537168` - Bayesian Networks in Pediatric Cardiac Surgery
Completed	`NCT05525195` - Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
Completed	`NCT04238806` - Desflurane,Brain Natriuretic Peptide and Cardiac Surgery	N/A
Completed	`NCT00981474` - Cerebral Autoregulation Monitoring During Cardiac Surgery	N/A
Recruiting	`NCT05588011` - Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass	N/A
Completed	`NCT02566733` - Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass	Phase 4
Terminated	`NCT00385450` - Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor	Phase 1
Completed	`NCT00246740` - Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting	Phase 2
Not yet recruiting	`NCT05075265` - Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation
Recruiting	`NCT04296071` - Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
Completed	`NCT05579964` - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot	Phase 2/Phase 3
Active, not recruiting	`NCT04133740` - Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study	Phase 4
Completed	`NCT05033236` - Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)