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Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

NCT ID: NCT01221116

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Heart Failure Cardiac Surgery

Keywords

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coronary artery disease, aortic stenosis, heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type NO_INTERVENTION

levosimendan

Intervention Type DRUG

levosimendan 0.1 microgram/kg/min) for 24 hours

Interventions

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levosimendan

levosimendan 0.1 microgram/kg/min) for 24 hours

Intervention Type DRUG

Other Intervention Names

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Type of surgery

Eligibility Criteria

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Inclusion Criteria

* EF (ejection fraction)\<40%

Exclusion Criteria

* renal failure, liver failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Knut Arvid Kirkebøen

Principal Investigators

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Knut A Kirkebøen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Locations

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Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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INSI-study

Identifier Type: -

Identifier Source: org_study_id