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Nesiritide Use Following Cardiac Surgery in Infants

This study has been terminated.
(Slow patient enrollment.)
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00281671
First received: January 23, 2006
Last updated: January 28, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Defects, Congenital
Cardiopulmonary Bypass
 Drug: nesiritide
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effects of Nesiritide on Hemodynamics and Urine Output Following Cardiopulmonary Bypass in Infants

Resource links provided by NLM:

Drug Information available for: Nesiritide
U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • urine output [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • urine output [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • cardiac index [ Time Frame: 6 horus ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: February 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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.
 Drug: nesiritide
nesiritide 0.015 mcg/kg/hour x 10 hours
Other Name: Natrecor

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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 48 hours after cardiac surgery requiring cardiopulmonary bypass
  • < 1 year of age
  • Receiving chlorothiazide and furosemide for > 12 hours
  • Urine output < 4 cc/kg/hour, or fluid intake > output for 2 consecutive days
  • Receiving mechanical ventilation
  • Presence of body wall edema on CXR, defined as a radiologic index of > 2
  • Plan for > 24 hrs further diuresis before chest closure or extubation

Exclusion Criteria:

  • Age > 365 days at the time of enrollment
  • Corrected estimated gestational age < 35 weeks at the time of enrollment
  • Serum creatinine > 2.0 mg/dL at the time of enrollment
  • Significant hemodynamic instability at the time of enrollment
  • Lack of dedicated intravenous access for nesiritide infusion
  • Lack of arterial line for continuous blood pressure monitoring
  • Lack of a Foley catheter for continuous urine collection
  • Enrollment in another research study such that the outcomes of either study may be confounded by participation in this study, or such that the amount of blood drawn for research purposes becomes excessive.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281671

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: John M Costello, MD Department of Cardiology, Children's Hospital Boston
  More Information

Publications:

Responsible Party: John M. Costello, MD MPH, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00281671     History of Changes
Other Study ID Numbers: 05-12-160
Study First Received: January 23, 2006
Last Updated: January 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Nesiritide
Natriuretic Peptide, Brain
Heart Defects, Congenital
Cardiopulmonary Bypass
Diuretics

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Natriuretic Peptide, Brain
 Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013