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Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

This study has been completed.
Information provided by:
Orion Corporation, Orion Pharma Identifier:
First received: August 15, 2005
Last updated: February 19, 2007
Last verified: February 2007
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00130871

Helsinki University Central Hospital
Helsinki, Finland, 00290
Turku University Central Hospital
Turku, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Principal Investigator: Markku Salmenperä, MD Helsinki University Central Hospital, Finland
  More Information Identifier: NCT00130871     History of Changes
Obsolete Identifiers: NCT00195832
Other Study ID Numbers: 3001079 
Study First Received: August 15, 2005
Last Updated: February 19, 2007
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Orion Corporation, Orion Pharma:
cardio-pulmonary bypass

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs processed this record on October 21, 2016