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Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

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ClinicalTrials.gov Identifier: NCT00130871
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : February 21, 2007
Information provided by:
Orion Corporation, Orion Pharma

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: levosimendan Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : January 2004
Estimated Study Completion Date : January 2006

Primary Outcome Measures :
  1. Proportion of successful primary weanings

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00130871     History of Changes
Obsolete Identifiers: NCT00195832
Other Study ID Numbers: 3001079
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: February 2007

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