Nesiritide Use Following Cardiac Surgery in Infants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-08

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Defects, Congenital Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% sodium chloride infusion

Nesiritide

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.

Group Type EXPERIMENTAL

nesiritide

Intervention Type DRUG

nesiritide 0.015 mcg/kg/hour x 10 hours

Interventions

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nesiritide

nesiritide 0.015 mcg/kg/hour x 10 hours

Intervention Type DRUG

Placebo

0.9% sodium chloride infusion

Intervention Type DRUG

Other Intervention Names

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Natrecor 0.9% sodium chloride infusion

Eligibility Criteria

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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.

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No