Levosimendan in High Risk Patients Undergoing Cardiac Surgery (HSR-LEVO)

This study is currently recruiting participants.
Verified April 2014 by Università Vita-Salute San Raffaele
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00994825
First received: October 7, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.


Condition Intervention Phase
Low Cardiac Output Syndrome
Drug: Levosimendan
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients. A Multicentre Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Study Start Date: November 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
"Soluvit" ATC BO5XC (a mixture of vitamins with a yellow colour that is indistinguishable from the study drug Levosimendan) half ampul in 100 ml of glucose 5%
Drug: placebo
"Soluvit" ATC BO5XC (a mixture of vitamins with a yellow colour that is indistinguishable from the study drug Levosimendan) half ampul in 100 ml of glucose 5%
Other Name: placebo
Experimental: Levosimendan Drug: Levosimendan
Other Name: simdax

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994825

Contacts
Contact: giovanni landoni, MD landoni.giovanni@hsr.it

Locations
Italy
Azienda Ospedaliera Universitaria "Mater Domini" Recruiting
Catanzaro, Italy
Contact: Gabriele Alvaro, MD       gabrielealvaro@libero.it   
Ospedale San Raffaele di Milano, Italy Recruiting
Milano, Italy, 20132
Contact: giovanni landoni, MD         
Ospedale San Gerardo di Monza Not yet recruiting
Monza, Italy
Azienda Ospedaliera Universitaria Pisana Recruiting
Pisa, Italy
Contact: Fabio Guarracino, MD       fabiodoc64@hotmail.com   
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Chair: Alberto Zangrillo, MD Vita-Salute University of Milano
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00994825     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 768/DG
Study First Received: October 7, 2009
Last Updated: April 4, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
levosimendan
cardiac surgery
cardiac anesthesia
mortality
survival
inotropic drugs

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014