Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
This study has been terminated.
(The study was stopped due to difficulties in including patients)
Sponsor:
Ullevaal University Hospital
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT01221116
First received: October 13, 2010
Last updated: November 1, 2010
Last verified: January 2003
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Purpose
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit
| Condition | Intervention |
|---|---|
|
Heart Failure Cardiac Surgery |
Drug: levosimendan |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery |
Resource links provided by NLM:
Further study details as provided by Ullevaal University Hospital:
Primary Outcome Measures:
- Need for inotropic agents or IABP (intra aortal balloon pump) [ Time Frame: jan 2003 - dec 2008 ] [ Designated as safety issue: No ]
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. [ Time Frame: jan 2003-dec 2008 ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | January 2003 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1: Type of surgery
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)
|
Drug: levosimendan
levosimendan 0.1 microgram/kg/min) for 24 hours
Other Name: Type of surgery
|
Detailed Description:
Single center, prospective, randomized parallel-group, double-blinded study
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- EF (ejection fraction)<40%
Exclusion Criteria:
- renal failure, liver failure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221116
Locations
| Norway | |
| Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital | |
| Oslo, Norway, 0407 | |
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
| Principal Investigator: | Knut A Kirkebøen, MD, PhD | Ullevaal University Hospital |
More Information
No publications provided
| Responsible Party: | Ullevaal University Hospital, Knut Arvid Kirkebøen |
| ClinicalTrials.gov Identifier: | NCT01221116 History of Changes |
| Other Study ID Numbers: | INSI-study |
| Study First Received: | October 13, 2010 |
| Last Updated: | November 1, 2010 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by Ullevaal University Hospital:
|
coronary artery disease, aortic stenosis, heart failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular 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