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Preoperative Levosimendan and Heart Failure

NCT01022983 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-12-17

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and efficacy of Levosimendan given preoperative to patients with heart failure undergoing noncardiac surgery.

Conditions

Interventions

DRUG

Levosimendan

At least 2 hours before surgery: Infusion of Levosimendan (0,1 microgram/kg/min.). 24 hours of infusion without a bolus.

DRUG

Placebo

ml/kg/hours - same infusion rate as active comparator

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    collaborator INDUSTRY

  • Sykehuset i Vestfold HF

    lead OTHER

Principal Investigators

  • Espen Lindholm, MD · Vestfold Hospital trust, Norway

  • Knut A Kirkebøen, PhD · Oslo University Hospital - Ullevål, Norway

  • Mathias Kotyra, Md · Mölndal hospital, Sweden

  • Anders Nydahl, Phd · University Hospital Örebro, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01022983 on ClinicalTrials.gov