BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.

What Was Tested

This registered phase 1, phase 2 trial tested BNP (Nesiritide) for kidney protection (ckd, diabetic kidney, lupus kidney).

Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: cardiogenic shock or hypotension with systolic bp \< 90 mmhg; patients with acute or chronic aortic dissection; patients who are enrolled in other studies that have an effect the renal function.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

Neither the kidney protection (ckd, diabetic kidney, lupus kidney) 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 and investigator.

It started in 2003-03 with completion listed for 2007-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula (time frame: 72 hours post op).

It also tracked 5 secondary outcomes, for example Number of patients requiring dialysis during the hospitalization, Plasma aldosterone levels at 12 hours and 24 hours, Total time on ventilator, ICU length of stay, total length of stay in hospital and Need or absence of need for inotropic support in the 72 hour perioperative period.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 40 people with kidney protection (ckd, diabetic kidney, lupus kidney).

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, Kidney protection (CKD, diabetic kidney, lupus kidney) research.