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Levosimendan Versus Dobutamine in Shock Patients

Information source: Wentworth Area Health Services
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiogenic Shock; Septic Shock

Intervention: Levosimendan (Drug); Dobutamine (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Wentworth Area Health Services

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Resolution of shock state

Secondary outcome: Change in cardiac functions

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Intensive Care Unit, Nepean Hospital, Penrith, New South Wales 2750, Australia; Recruiting
Anthony S McLean, MD, Phone: +61-2-47342490, Email: mcleana@wahs.nsw.gov.au
Stephen J Huang, PhD, Phone: +61-247342320, Email: huangs@wahs.nsw.gov.au
Anthony S McLean, MD, Principal Investigator
Stephen J Huang, PhD, Sub-Investigator
Ian Seppelt, MD, Sub-Investigator
Marek Nalos, MD, Sub-Investigator
Additional Information

Starting date: October 2004
Last updated: June 23, 2005

Page last updated: August 20, 2015

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