Does Nesiritide Provide Renal Protection

What Was Tested

The trial (phase 2) is built around BNP (Nesiritide).

This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 37 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic valve or mitral valve surgery. Signed Informed Consent.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: age \<18 or \>80; presence of endocarditis or other infection; presence or anticipated use of an intra-aortic balloon pump.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2010-04 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Measure Neutrophils to Measure Kidney Injury (time frame: 30 days from the start of infusion). The Examine and Measure Cytokines to Measure Kidney Injury (time frame: 30 days from the start of infusion). The Examine and Measure Endothelin-1 to Measure Kidney Injury (time frame: 30 days from the start of infusion).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 37 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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