Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)
NCT ID: NCT00093886
Last Updated: 2014-05-06
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
PHASE3
629 participants
INTERVENTIONAL
2004-04-30
2005-04-30
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
NONE
Study Groups
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clevidipine
Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above 3.2 μg/kg/min were permitted up to the maximum infusion rate of 8.0 μg/kg/min. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Infusion rates between 4.4 and 8.0 μg/kg/min were to be administered for no more than 2 hours.
clevidipine
nitroglycerin
Nitroglycerin (NTG) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU.
nitroglycerin
Interventions
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clevidipine
nitroglycerin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age
* Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery
* Determined to be hypertensive perioperatively as determined by the investigator
Exclusion Criteria
* Recent cerebrovascular accident (within 3 months before randomization)
* Known intolerance to calcium channel blockers
* Known or suspected hypersensitivity to nitroglycerin
* Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
* Pre-existing permanent ventricular pacing
* Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
* Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study
18 Years
ALL
No
Sponsors
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The Medicines Company
INDUSTRY
Responsible Party
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Principal Investigators
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Malcolm Lloyd, MD
Role: STUDY_DIRECTOR
The Medicines Company - Medical Director, Clinical Operations
Locations
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Brookwood Medical Center
Birmingham, Alabama, United States
Baptist Medical Center, Montclair
Birmingham, Alabama, United States
Medical Center East
Birmingham, Alabama, United States
Baptist Medical Center, South
Montgomery, Alabama, United States
University Medical Center
Tucson, Arizona, United States
Saddleback Memorial Medical Center
Laguna Hills, California, United States
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
University of California
San Francisco, California, United States
Regional Medical Center - Bayonet Point
Hudson, Florida, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, United States
Sacred Heart Health System
Pensacola, Florida, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Saint Francis Hospital
Evanston, Illinois, United States
Wesley Medical Center
Wichita, Kansas, United States
St Joseph Medical Center
Towson, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
New York University Medical Center
New York, New York, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
The Christ Hospital, The Linder Clinical Trial Center
Cincinnati, Ohio, United States
Portland VA Medical Center
Portland, Oregon, United States
Memorial Herman Memorial City Hospital
Houston, Texas, United States
Michael E DeBakey VA Medical Center
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Houston Northwest Medical Center
Houston, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Countries
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References
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Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.
Other Identifiers
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TMC-CLV-03-03
Identifier Type: -
Identifier Source: org_study_id
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