Natrecor for Pulmonary Hypertension in Lung Transplants

What Was Tested

In this phase 4 trial, researchers set out to test BNP (Nesiritide).

It had 1 arm (groups): Natrecor infusion (experimental).

Nesiritide.

The registry classes the interventions as drug.

More on the Plan

A condition called ischemic reperfusion injury (IRI) occurs in all lung transplants.

The amount of reperfusion injury varies from person to person.

Nitric Oxide (NO) is given by inhalation while patients are on a ventilator (breathing machine).

Because NO must be given by a ventilator and because patients on ventilators must be in an intensive care unit, the cost of treating people with NO is very high.

Who Took Part

Enrollment: 7 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.

Examples of who could join: Single or double lung transplant or heart/lung transplant recipient. Planned use of Natrecor. Pulmonary artery (PA) systolic pressures \> 35.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: previous lung transplant; use of prolastin after pneumonectomy; mean arterial pressure of \< 55.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Being open-label, the BNP (Nesiritide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-08 with completion listed for 2006-05.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 10 secondary outcomes, for example To compare length of stay in the Intensive Care Unit (ICU), To compare renal function as defined by peak serum creatinine and calculated creatinine clearance during the first 72 hours post-transplant, To compare necessity of CPB between Natrecor® versus nitric oxide, To compare hemodynamic parameters, To compare length of stay (total) and To compare time to dry weight.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of BNP (Nesiritide) in 7 people.

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

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, all human trials.