Evidence map›Paper›PMID 35063963›Full record

ArticleBMJ open2022

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.

Christian Reiterer, Barbara Kabon, Alexander Taschner, Nikolas Adamowitsch, Alexandra Graf, Melanie Fraunschiel, Katharina Horvath, Melanie Kuhrn, Theresa Clement, Sascha Treskatsch and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04329624 (The Effect of Perioperative LevosIMendan Administration on Postoperative N-terminal pRo Brain Natriuretic Peptide Concentration in Patients With Increased cardiOVascular Risk Factors Undergoing Noncardiac surgEry - A Double-blinded Randomized Clinical Trial), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04329624 phase3completednot on this map

The Effect of Perioperative LevosIMendan Administration on Postoperative N-terminal pRo Brain Natriuretic Peptide Concentration in Patients With Increased cardiOVascular Risk Factors Undergoing Noncardiac surgEry - A Double-blinded Randomized Clinical Trial

TypeinterventionalSponsorMedical University of ViennaRan2020 to 2024Enrolled230ConditionsCardiovascular Risk FactorArmsLevosimendan, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 3 countries.

Christian ReitererDepartment of Anesthesia, Intensive Care Medicine and Pain Medicine, Outcome Research Consortium, Cleveland, Ohio, USA.ORCID 0000-0002-8055-6038
Barbara KabonDepartment of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Wien, Austria barbara.kabon@meduniwien.ac.at.
Alexander TaschnerDepartment of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Wien, Austria.
Nikolas AdamowitschDepartment of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Wien, Austria.
Alexandra GrafCenter for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Wien, Austria.
Melanie FraunschielITSC - IT Systems & Communications, Medical University of Vienna, Wien, Austria.
Katharina HorvathDepartment of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Wien, Austria.
Melanie KuhrnDepartment of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Wien, Austria.
Theresa ClementDepartment of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Wien, Austria.
Sascha TreskatschDepartment of Anesthesiology and Intensive Care Medicine, Charite Universitatsmedizin Berlin, Berlin, Germany.
Christian BergerDepartment of Anesthesiology and Intensive Care Medicine, Charite Universitatsmedizin Berlin, Berlin, Germany.
Edith FleischmannDepartment of Anesthesia, Intensive Care Medicine and Pain Medicine, Outcome Research Consortium, Cleveland, Ohio, USA.
Medical University of Vienna · ATCharité - Universitätsmedizin Berlin · DEOutcomes Research Consortium · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionElevated N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after non-cardiac surgery is a strong predictor for cardiovascular complications and reflects increased myocardial strain. NT-pro-BNP concentrations significantly rise after non-cardiac surgery within the first 3 days. Levosimendan is a potent inotropic drug that increases calcium sensitivity to cardiac myocytes, which results in improved cardiac contractility that last for approximately 7 days. Thus, we 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. METHODS AND ANALYSIS: We 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. Patients will be randomly assigned to receive a single dose of 12.5 mg levosimendan versus placebo after induction of anaesthesia. The primary outcome will be the postoperative maximum NT-pro-BNP concentration between both group within the first three postoperative days. Our secondary outcomes will be the incidence of myocardial ischaemia, myocardial injury after non-cardiac surgery and a composite of myocardial infarction and death within 30 days and 1 year after surgery between both groups. Our further secondary outcome will be stratification of NT-pro-BNP values according to previously thresholds to predict mortality of myocardial infarction after surgery. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Medical University of Vienna on 14 July 2020 (EK 2187/2019). Written informed consent will be obtained from all patients a day before surgery. Results of this study will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04329624.

Indexed as

Cardiovascular DiseasesNatriuretic Peptide, BrainBiomarkersHeart Disease Risk FactorsHumansPeptide FragmentsProspective StudiesRandomized Controlled Trials as TopicRisk FactorsSimendanBiomarkersNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)Simendanadult anaesthesiaclinical trialsheart failure

Identifiers

PMID35063963
PMCPMC8785196
OpenAlexW4206939095

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.