Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure

What Was Tested

In this not phased trial, researchers set out to test BNP (Nesiritide).

It had two arms (groups): rhBNP in the treatment of sepsis complicated with heart failure (experimental) and Conventional treatment group (no intervention).

Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure.

Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure.

The registry classes the interventions as drug.

More on the Plan

Sepsis is one of the common critical diseases in ICU with high mortality.

The investigators are going to carry out related research from the following aspects: 1.

To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2.

To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3.

Who Took Part

70 planned participants were the target.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Sepsis complicated with heart failure（Diagnosed by sepsis 3.0）. Heart failure: BNP rises by 600 pg/ml. Age\>=18 years old.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: hemodynamically unstable; disagree with comprehensive and active life support treatment; coronary heart disease, myocardial infarction, and cardiac insufficiency.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

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

Only one side, usually the participants, was kept unaware of whether BNP (Nesiritide) was given.

Those kept unaware of assignments: participant.

It started in 2021-12-01 with completion listed for 2023-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function (time frame: 72 hours after rhBNP). PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group (time frame: 72 hours after recombinant human brain natriuretic peptide).

It also tracked 2 secondary outcomes, for example Mechanical ventilation time after entering ICU.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of BNP (Nesiritide) in 70 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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