Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
The Medicines Company
Study ID
NCT00093925
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after 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 nicardipine.

Key Dates

Start date
May 31, 2004
Status verified
May 2014
Primary completion
Jul 31, 2006
Completion
Sep 30, 2006

Study Design

Enrollment
739 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: clevidipine
    Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of postoperative 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.
  • Active Comparator: nicardipine
    Nicardipine (NIC) was initiated after insertion of an arterial line upon the occurrence of postoperative 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.

Primary Outcome Measure

Incidence of death, stroke, MI, and renal dysfunction [ Time Frame: Initiation of study drug infusion through post-operative Day 30 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Mobile Infirmary Medical CenterMobileAlabama36607-
Wesley Medical CenterWichitaKansas67214-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Touro InfirmaryNew OrleansLouisiana70115-
Columbia University - College of Physicians and SurgeonsNew YorkNew York10032-
Jack D. Weller HospitalThe BronxNew York10461-
Montefiore Medical CenterThe BronxNew York10467-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
VA Medical Center McGuireRichmondVirginia23249-

Find similar trials in Mobile, AL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Mobile Infirmary Medical Center· Mobile, ALWesley Medical Center· Wichita, KSOchsner Clinic Foundation· New Orleans, LATouro Infirmary· New Orleans, LAColumbia University - College of Physicians and Surgeons· New York, NYJack D. Weller Hospital· The Bronx, NY

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