Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 15, 2005

Last Updated Date

February 19, 2007

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

Proportion of successful primary weanings

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00130871 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

Official Title ^†

Impact of Levosimendan Pretreatment on Weaning From Cardiopulmonary Bypass (CPB) in Patients With Diminished Left Ventricular Function Before Coronary Artery Bypass Grafting (CABG)

Brief Summary

The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.

Detailed Description

Levosimendan or placebo infusion is started at the time of induction of anesthesia.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Coronary Heart Disease

Intervention ^†

Drug: levosimendan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Three vessel coronary artery disease.
Indication for on-pump coronary artery bypass surgery.
Ejection fraction below 50%

Exclusion Criteria:

Indication for any cardiac valve surgery
Previous coronary artery bypass surgery

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Finland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00130871

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Orion Corporation, Orion Pharma

Collaborators ^††

Investigators ^†

Principal Investigator:

Markku Salmenperä, MD

Helsinki University Central Hospital, Finland

Information Provided By

Orion Corporation, Orion Pharma

Verification Date

February 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.