Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
NCT ID: NCT00093262
Last Updated: 2014-05-08
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
206 participants
INTERVENTIONAL
2003-12-31
2004-10-31
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
TRIPLE
Study Groups
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clevidipine
Clevidipine was administered in a blinded fashion intravenously, starting with an infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/hr), titrating upward, as tolerated by the patient, in doubling increments approximately every 90 seconds up to an infusion rate of 3.2 μg/kg/min (16 mg/hr) to achieve the desired blood pressure-lowering effect. Up-titration to infusion rates above 3.2 μg/kg/min could be used, guided by the patient's response, by increasing the infusion rate in serial increments of 1.5 μg/kg/min, up to the maximum recommended clevidipine infusion rate of 8.0 μg/kg/min. Clevidipine was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.
clevidipine
placebo
Placebo consisted of 20% lipid emulsion (the same lipid vehicle used for clevidipine) administered in a blinded fashion intravenously following the same study drug administration guidelines as with clevidipine study drug administration guidelines. As with clevidipine, placebo was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.
placebo
Interventions
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clevidipine
placebo
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 cardiac surgery (including Coronary Artery Bypass Grafting \[CABG\], Off Pump Coronary Artery Bypass \[OPCAB\], Minimally Invasive Direct Coronary Artery Bypass \[MIDCAB\] surgery, and/or valve replacement/repair procedures)
* Expected to survive beyond 24 hours post-surgical procedure
* No surgical complications or conditions, present or anticipated, that preclude them from inclusion in a double blind, placebo-controlled study
* Determined to be hypertensive (SBP \> 140 mm Hg) within 4 hours of arrival in a postoperative setting
* It is the investigator's intent to lower the patient's SBP by a minimum of 15% from its baseline value
Exclusion Criteria
* Recent cerebrovascular accident (within 3 months before randomization)
* Known intolerance to calcium channel blockers
* Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
* Pre-existing left bundle branch block or 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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Locations
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Discovery Alliance - Mobile Infirmary Medical Center
Mobile, Alabama, United States
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Stanford University School of Medicine
Stanford, California, United States
Emory Hospital
Atlanta, Georgia, United States
Heart Care Research Foundation
Blue Island, Illinois, United States
MacNeal Hospital
Glencoe, Illinois, United States
Wesley Medical Center
Wichita, Kansas, United States
St. Lukes Hospital
Kansas City, Missouri, United States
International Heart Institute
Missoula, Montana, United States
Mt. Sinai Medical Center
New York, New York, United States
Columbia University - College of Physicians and Surgeons
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion
Houston, Texas, United States
Medical College of Wisconsin VAMC - Milwaukee
Milwaukee, Wisconsin, United States
Countries
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References
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Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.
Other Identifiers
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ESCAPE-2
Identifier Type: -
Identifier Source: secondary_id
TMC-CLV-03-02
Identifier Type: -
Identifier Source: org_study_id
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