?Levosimendan to reduce mortality in high risk cardiac surgery patients. A multicentre randomized controlled trial.? - ND

• Conditions: high risk cardiac surgery affected by low cardiac output syndrome (LCOs); MedDRA version: 9.1Level: SOCClassification code 10007541

• Registration Number: EUCTR2009-013066-31-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-conseso informato scritto
-eta` superiore ai 18 anni
-disfunzione miocardica perioperatoria definita sindrome da bassa gittata etc.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

trapianto del rene o del fegato; -previous unusual response to levosimendan or soluvit or any of their components
-inclusion in other randomised controlled studies in the previous 30 days
-levosimendan administration in the previous 30 days
-Parkinson?s desease
-emergency operation
-Kidney or liver transplant
-Liver cirrhosis (Child B or C)
-decision to use ECMO (ECMO already started or planned)
-do not resuscitate patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified