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Nesiritide Use Following Cardiac Surgery in Infants

NCT00281671 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-08-27

Study results available
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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.

Conditions

  • Heart Defects, Congenital
  • Cardiopulmonary Bypass

Interventions

DRUG

nesiritide

nesiritide 0.015 mcg/kg/hour x 10 hours

DRUG

Placebo

0.9% sodium chloride infusion

Sponsors & Collaborators

Principal Investigators

  • John M Costello, MD · Department of Cardiology, Children's Hospital Boston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-08
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00281671 on ClinicalTrials.gov