Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Not Applicable

Terminated

• Conditions: Cardiac Surgery; Heart Failure
• Interventions: Drug: levosimendan

• Registration Number: NCT01221116
• Lead Sponsor: Ullevaal University Hospital

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

Study Timeline

• Status Verified: 2003-01
• Study Start: 2003-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• EF (ejection fraction)<40%

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Exclusion Criteria

• renal failure, liver failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Type of surgery	levosimendan	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)

Primary Outcome Measures

Name	Time	Method
Need for inotropic agents or IABP (intra aortal balloon pump)	jan 2003 - dec 2008

Secondary Outcome Measures

Name	Time	Method
Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.	jan 2003-dec 2008

Trial Locations

Locations (1)

Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital; 🇳🇴 Oslo, Norway