Back to results

Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

Primary Purpose

Coronary Heart Disease

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

levosimendan

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring levosimendan, weaning, cardio-pulmonary bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University Central Hospital
Turku University Central Hospital

Outcomes

Primary Outcome Measures

Proportion of successful primary weanings

Secondary Outcome Measures

Full Information

NCT ID

NCT00130871

First Posted

August 15, 2005

Last Updated

February 19, 2007

Sponsor

Orion Corporation, Orion Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00130871

Brief Title

Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

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 Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Orion Corporation, Orion Pharma

4. Oversight

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

levosimendan, weaning, cardio-pulmonary bypass

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

levosimendan

Primary Outcome Measure Information:

Title

Proportion of successful primary weanings

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markku Salmenperä, MD

Organizational Affiliation

Helsinki University Central Hospital, Finland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Turku University Central Hospital

City

Turku

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass

We'll reach out to this number within 24 hrs