Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Ullevaal University Hospital23 enrolled

Overview

Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit

Single center, prospective, randomized parallel-group, double-blinded study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Failure Cardiac Surgery

Interventions

levosimendanDRUG

levosimendan 0.1 microgram/kg/min) for 24 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * EF (ejection fraction)\<40% Exclusion Criteria: * renal failure, liver failure

Locations (1)

Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital

Oslo, Oslo, Norway

Outcomes

Primary Outcomes

Need for inotropic agents or IABP (intra aortal balloon pump)

Time frame: jan 2003 - dec 2008

Secondary Outcomes

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

Data from ClinicalTrials.gov

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