Back to resultsInotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Primary Purpose
Heart Failure, Cardiac Surgery
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
levosimendan
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring coronary artery disease,, aortic stenosis,, heart failure
Eligibility Criteria
Inclusion Criteria:
- EF (ejection fraction)<40%
Exclusion Criteria:
- renal failure, liver failure
Sites / Locations
- Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
1: Type of surgery
Arm Description
Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)
Outcomes
Primary Outcome Measures
Need for inotropic agents or IABP (intra aortal balloon pump)
Secondary Outcome Measures
Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.
Full Information
NCT ID
NCT01221116
First Posted
October 13, 2010
Last Updated
November 1, 2010
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01221116
Brief Title
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Official Title
Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2003
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to difficulties in including patients
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit
Detailed Description
Single center, prospective, randomized parallel-group, double-blinded study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Surgery
Keywords
coronary artery disease,, aortic stenosis,, heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Type of surgery
Arm Type
No Intervention
Arm Description
Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)
Intervention Type
Drug
Intervention Name(s)
levosimendan
Other Intervention Name(s)
Type of surgery
Intervention Description
levosimendan 0.1 microgram/kg/min) for 24 hours
Primary Outcome Measure Information:
Title
Need for inotropic agents or IABP (intra aortal balloon pump)
Time Frame
jan 2003 - dec 2008
Secondary Outcome Measure Information:
Title
Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.
Time Frame
jan 2003-dec 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
EF (ejection fraction)<40%
Exclusion Criteria:
renal failure, liver failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut A Kirkebøen, MD, PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
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Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
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