Effect of perioperative levosimendan administration on postoperative N-terminal pro-B-type natriuretic peptide concentration in patients with increased cardiovascular risk factors undergoing non-cardiac surgery: protocol for the double-blind, randomised, placebo-controlled IMPROVE trial

What Was Tested

Researchers studied BNP (Nesiritide) in this clinical study publication.

Thus, the researchers will test the effect of a pre-emptive perioperative administration of levosimendan on postoperative NT-pro-BNP concentration as compared with the administration of a placebo in patients undergoing moderate-risk to high-risk major abdominal surgery.

The study was approved by the Ethics Committee of the Medical University of Vienna on 14 July 2020 (EK 2187/2019).

Who Took Part

The study group was 230 patients.

The researchers will conduct a double-blinded prospective randomised trial at the Medical University of Vienna, Vienna, Austria (and potentially a second centre in Germany), including 230 patients at-risk for cardiovascular complications undergoing moderate- to high-risk major abdominal surgery.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

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

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

Some patients received a placebo instead of BNP (Nesiritide), giving a reference point.

The primary outcome will be the postoperative maximum NT-pro-BNP concentration between both group within the first three postoperative days.

Their further secondary outcome will be stratification of NT-pro-BNP values according to previously thresholds to predict mortality of myocardial infarction after surgery.

What Was Measured

Thus, the researchers will test the effect of a pre-emptive perioperative administration of levosimendan on postoperative NT-pro-BNP concentration as compared with the administration of a placebo in patients undergoing moderate-risk to high-risk major abdominal surgery.

The subject headings attached to it are Biomarkers, Cardiovascular Diseases, Heart Disease Risk Factors, Natriuretic Peptide, Brain, Peptide Fragments, Randomized Controlled Trials as Topic and Risk Factors.

Author keywords: adult anaesthesia, clinical trials and heart failure.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of BNP (Nesiritide) in 230 patients.

The publication is from 2022 (BMJ open), a journal based in England.

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