Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)
- Registration Number
- NCT00093912
- Lead Sponsor
- The Medicines Company
- Brief Summary
The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 250-500 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or sodium nitroprusside.
- Detailed Description
The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and sodium nitroprusside treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect and additional safety variables.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 739
- Provide written informed consent before initiation of any study related procedures.
- 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
Prerandomization
- Women of child-bearing potential (unless they have a negative pregnancy test)
- Recent cerebrovascular accident (within 3 months before randomization)
- Known intolerance to calcium channel blockers
- Known or suspected hypersensitivity to sodium nitroprusside
- 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
Postrandomization Inclusion Criteria:
- Determined to be hypertensive perioperatively as determined by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sodium nitroprusside sodium nitroprusside Sodium nitroprusside (SNP) 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. clevidipine 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.
- Primary Outcome Measures
Name Time Method Incidence of death, stroke, MI and renal dysfunction Initiation of study drug infusion through post-operative Day 30
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Saint Vincents Hospital
🇺🇸Birmingham, Alabama, United States
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Baptist Medical Center, Montclair
🇺🇸Birmingham, Alabama, United States
Baptist Medical Center, South
🇺🇸Montgomery, Alabama, United States
Drug Research and Analysis Corporation
🇺🇸Montgomery, Alabama, United States
Providence Saint Joseph Medical Center
🇺🇸Burbank, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Shands Hospital at the University of Florida
🇺🇸Gainesville, Florida, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Kaiser Permanente
🇺🇸Honolulu, Hawaii, United States
Scroll for more (19 remaining)Saint Vincents Hospital🇺🇸Birmingham, Alabama, United States