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Levosimendan in High Risk Patients Undergoing Cardiac Surgery (CHEETAH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994825
First Posted: October 14, 2009
Last Update Posted: July 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Giovanni Landoni, Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30-days ]

Estimated Enrollment: 1000
Study Start Date: November 2009
Study Completion Date: May 2016
Primary Completion Date: May 2016 (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%
Experimental: Levosimendan
Levosimendan
Drug: Levosimendan
Other Name: simdax

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994825


Locations
Brazil
Santa Casa de Misericórdia de Juiz de Fora
Juiz de Fora, Minas Gerais, Brazil, 36.021- 630
Italy
Azienda Ospedaliera Ospedali Riuniti Papardo - Piemonte
Messina, ME, Italy, 98158
A.O.U. Citta della Salute e della Scienza
Torino, TO, Italy, 10126
A. O. Ordine Mauriziano di Torino
Torino, TO, Italy
Ospedale San Bortolo
Vicenza, VI, Italy
Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria "Mater Domini"
Catanzaro, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Ospedale San Raffaele di Milano, Italy
Milano, Italy, 20132
Ospedale San Gerardo di Monza
Monza, Italy
Azienda Ospedaliera Specialistica dei Colli
Napoli, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Azienda Ospedaliera Regionale San Carlo
Potenza, Italy, 85100
Ospedale Civile SS Annunziata
Sassari, Italy
Russian Federation
Astrakhan Federal Centre for Cardiac Surgery
Astrakhan, Russia, Russian Federation, 414000
Scientific Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, Russia, Russian Federation, 650002
Moscow Regional Clinical & Research Institute
Moscow, Russia, Russian Federation, 129110
Research Institute of Circulation Pathology
Novosibirsk, Russia, Russian Federation, 630055
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Study Chair: Alberto Zangrillo, MD Vita-Salute University of Milano
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giovanni Landoni, Head of Research, Anesthesia and Intensive Care Department, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT00994825     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 768/DG
First Submitted: October 7, 2009
First Posted: October 14, 2009
Last Update Posted: July 22, 2016
Last Verified: July 2016

Keywords provided by Giovanni Landoni, 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
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs