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Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients

NCT04329624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-05-08

No results posted yet for this study

Summary

This is a prospective randomised trial investigating the effect of a preemptive administration of levosimendan on postoperative cardiac NT-proBNP concentrations.

Conditions

  • Cardiovascular Risk Factor

Interventions

DRUG

Levosimendan

Levosimendan 2.5 mg/ml injection contains levosimendan 2.5 mg, povidone 10.0 mg, citric acid, anhydrous 2.0 mg and ethanol, anhydrous to 1.0 mL. Levosimendan injection is a clear, yellow to orange solution. Immediately after skin incision patients allocated to the verum group will receive a dose of 12.5 mg in 500 mL of levosimendan.

DRUG

Placebo

Placebo 2.5 mg/ml injection contains riboflavine sodium phosphate 0.4 mg, dehydrated alcohol 100 mg and water for injection to 1 mL. Immediately after skin incision patients allocated to the placebo group will receive 500 mL of 5% Glucose.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-10
Primary Completion
2023-11-07
Completion
2024-12-18

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329624 on ClinicalTrials.gov