Status:

COMPLETED

Levosimendan in High Risk Patients Undergoing Cardiac Surgery

Lead Sponsor:

Università Vita-Salute San Raffaele

Conditions:

Low Cardiac Output Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term...

Detailed Description

Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term...

Eligibility Criteria

Inclusion

  • Written informed consent
  • Age \> 18 years
  • Perioperative myocardial dysfunction

Exclusion

  • 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 disease
  • 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

Key Trial Info

Start Date :

November 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2016

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT00994825

Start Date

November 1 2009

End Date

May 1 2016

Last Update

July 22 2016

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Santa Casa de Misericórdia de Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil, 36.021- 630

2

Policlinico S.Orsola-Malpighi

Bologna, Italy, Italy, 40138

3

Azienda Ospedaliera Universitaria San Martino

Genova, Italy, Italy, 16132

4

Azienda Ospedaliera Ospedali Riuniti Papardo - Piemonte

Messina, ME, Italy, 98158