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Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00130871
First received: August 15, 2005
Last updated: February 19, 2007
Last verified: February 2007
History of Changes
  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 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)

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov 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:
levosimendan
weaning
cardio-pulmonary bypass

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Simendan
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013