- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00610350
Levosimendan and Myocardial Protection
February 6, 2008 updated by: University of Roma La Sapienza
Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rome, Italy, 00155
- University of Rome "Sapienza"
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age ≥18 years
- intention to perform first-time multi-vessel CABG
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: L
|
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
|
Experimental: P
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of ICU stay
Time Frame: two weeks
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: 3 weeks
|
3 weeks
|
Tracheal intubation time
Time Frame: one week
|
one week
|
Inotropic support over the first 7 days
Time Frame: one week
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vincenzo De Santis, M.D., University of Roma La Sapienza
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (Estimate)
February 7, 2008
Study Record Updates
Last Update Posted (Estimate)
February 7, 2008
Last Update Submitted That Met QC Criteria
February 6, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LV 2003
- LV-2003-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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