We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130871
First Posted: August 16, 2005
Last Update Posted: February 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Orion Corporation, Orion Pharma
  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
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)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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


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

ClinicalTrials.gov Identifier: NCT00130871     History of Changes
Obsolete Identifiers: NCT00195832
Other Study ID Numbers: 3001079
First Submitted: August 15, 2005
First Posted: August 16, 2005
Last Update Posted: February 21, 2007
Last Verified: February 2007

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

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