Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

This study has been completed.

Sponsored by:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00130871

Purpose

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

Condition	Intervention	Phase
Coronary Heart Disease	Drug: levosimendan	Phase II

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Heart Diseases

Drug Information available for: Levosimendan Simendan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Proportion of successful primary weanings

Estimated Enrollment:	60
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2006

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130871

Locations

Finland
Helsinki University Central Hospital
Helsinki, Finland, 00290
Turku University Central Hospital
Turku, Finland

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Principal Investigator:

Markku Salmenperä, MD

Helsinki University Central Hospital, Finland

More Information

Study ID Numbers:	3001079
Study First Received:	August 15, 2005
Last Updated:	February 19, 2007
ClinicalTrials.gov Identifier:	NCT00130871
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Orion Corporation, Orion Pharma:

levosimendan
weaning
cardio-pulmonary bypass

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Coronary Artery Disease
Simendan

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009