MedTrace Logo

Preoperative Levosimendan in CABG Patients With Poor LV Function

NCT02184819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2016-02-25

No results posted yet for this study

Summary

The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function (EF 40% or less).

Conditions

  • Coronary Artery Bypass Grafting
  • Left Ventricular Dysfonction

Interventions

DRUG

levosimendan

24 hour continuous infusion at the rate of 0,1 µg/kg/min

DRUG

Placebo

24 hour infusion at a rate of 0,1 µg/kg/min assuming that it contains study drug

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bernard Cholley, MD, PhD · Anesthesiology and Intensive Care, Hopital Européen Georges Pompidou, Paris, France

  • Thibaut Caruba, PharmD · Pharmacy department, Hopital Européen Georges Pompidou, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-11-30

Countries

  • France

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 NCT02184819 on ClinicalTrials.gov