Levosimendan and Myocardial Protection
Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial
2 other identifiers
interventional
100
1 country
1
Brief Summary
The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2005
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedFebruary 7, 2008
January 1, 2008
2.1 years
January 24, 2008
February 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of ICU stay
two weeks
Secondary Outcomes (3)
Length of hospital stay
3 weeks
Tracheal intubation time
one week
Inotropic support over the first 7 days
one week
Study Arms (2)
L
EXPERIMENTALP
EXPERIMENTALInterventions
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
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
You may qualify if:
- age ≥18 years
- intention to perform first-time multi-vessel CABG
You may not qualify if:
- unstable angina
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rome "Sapienza"
Rome, 00155, Italy
Related Publications (1)
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.
PMID: 19151048DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincenzo De Santis, M.D.
University of Roma La Sapienza
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
January 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
February 7, 2008
Record last verified: 2008-01