Study Results
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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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2005-01-31
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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L
levosimendan
24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
P
Placebo
an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
Interventions
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levosimendan
24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
Placebo
an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
Eligibility Criteria
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Inclusion Criteria
* intention to perform first-time multi-vessel CABG
Exclusion Criteria
* valvular disease
* diabetes mellitus treated with sulphonylurea drugs
* renal failure
* severe hepatic disease
* severe chronic obstructive pulmonary disease
* a history of prior CABG surgery
* recent myocardial infarction (MI) within the previous month
18 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
University of Roma La Sapienza
OTHER
Responsible Party
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University of Rome "Sapienza"
Principal Investigators
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Vincenzo De Santis, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Roma La Sapienza
Locations
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University of Rome "Sapienza"
Rome, , Italy
Countries
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References
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Tritapepe L, De Santis V, Vitale D, Guarracino F, Pellegrini F, Pietropaoli P, Singer M. Levosimendan pre-treatment improves outcomes in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2009 Feb;102(2):198-204. doi: 10.1093/bja/aen367.
Other Identifiers
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LV-2003-01
Identifier Type: -
Identifier Source: secondary_id
LV 2003
Identifier Type: -
Identifier Source: org_study_id
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