Nesiritide Use Following Cardiac Surgery in Infants

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test BNP (Nesiritide).

The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants.

It had two arms (groups): Placebo (placebo comparator) and Nesiritide (experimental).

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.

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.

The registry classes the interventions as drug.

More on the Plan

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 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.

Who Took Part

9 actual participants took part.

It was open to people of any sex aged up to 1 Year.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: \> 48 hours after cardiac surgery requiring cardiopulmonary bypass. \< 1 year of age. Receiving chlorothiazide and furosemide for \> 12 hours. Receiving mechanical ventilation. Presence of body wall edema on CXR, defined as a radiologic index of \> 2.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: age \> 365 days at the time of enrollment; corrected estimated gestational age \< 35 weeks at the time of enrollment; lack of dedicated intravenous access for nesiritide infusion.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got BNP (Nesiritide) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both BNP (Nesiritide) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on BNP (Nesiritide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-04-08 with completion listed for 2008-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Urine Output (time frame: 5 hours).

It also tracked 3 secondary outcomes, for example Number of Participants With Hypotension and Bradycardia, Urine Output and Cardiac Index.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the BNP (Nesiritide) compound page, all human trials.