Levosimendan Versus Dobutamine in Shock Patients

June 23, 2005 updated by: Wentworth Area Health Services

Efficacy of Levosimendan in the Critically Ill Patients With Unstable Hemodynamics (the LICI Study) - A Double Blind Randomized Pilot Study

The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Penrith, New South Wales, Australia, 2750
        • Recruiting
        • Intensive Care Unit, Nepean Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anthony S McLean, MD
        • Sub-Investigator:
          • Stephen J Huang, PhD
        • Sub-Investigator:
          • Ian Seppelt, MD
        • Sub-Investigator:
          • Marek Nalos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Reduced left ventricular systolic function
  • Hypotension
  • Anuria or oligouria

Exclusion Criteria:

  • Less than 18 years old
  • Pregnant
  • Uncorrected valvular stenosis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Third degree AV block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Resolution of shock state

Secondary Outcome Measures

Outcome Measure
Change in cardiac functions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wentworth Area Health Services

Collaborators

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

October 5, 2004

First Submitted That Met QC Criteria

October 6, 2004

First Posted (Estimate)

October 7, 2004

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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