Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)
The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)|
- Incidence of bailout during 30-minute treatment period [ Time Frame: During the first 30 minutes post study drug initiation ] [ Designated as safety issue: No ]
discontinuation of study drug categorized according to the following reasons:
- Bailout for lack of efficacy
- Bailout for safety reason(s)
- Bailout due to treatment failure
- Median time to target SBP lowering effect (defined as a reduction by 15% or more) [ Time Frame: During the first 30 minutes post study drug initiation ] [ Designated as safety issue: No ]
- Mean arterial pressure (MAP) change from baseline [ Time Frame: During the first 30 minutes post study drug initiation ] [ Designated as safety issue: No ]
- Heart rate change from baseline [ Time Frame: During the first 30 minutes post study drug initiation ] [ Designated as safety issue: No ]
- Incidence of bailout by causality [ Time Frame: During the first 30 minutes post study drug initiation ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||November 2004|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Clevidipine was administered in a blinded fashion by intravenous (IV) infusion, starting at a rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/hr) and titrating upward, as tolerated, in doubling increments approximately every 90 seconds to achieve the desired blood pressure-lowering effect. Up-titration to 3.2 μg/kg/min (16 mg/hr) was allowed. Infusion rates above 3.2 μg/kg/min could be used, guided by the patient's response, by increasing 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 (0.5 mg/mL in 20% lipid emulsion)will be administered intravenously at an initial infusion rate of 0.4 µg/kg/min and will be titrated, as tolerated, at the discretion of the investigator, in doubling increments approximately every 90 seconds up to a maximum of 3.2 µg/kg/min, in order to achieve the desired blood pressure lowering effect. Clevidipine may be titrated upwards or downwards and may be temporarily interrupted and restarted to attain the desired blood pressure effect. The maximum study drug infusion rate of 8.0 µg/kg/min may not be exceeded.
Other Name: clevidipine, Cleviprex
Placebo Comparator: 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 (20% lipid emulsion - vehicle) will be administered intravenously in a fashion identical to clevidipine as described above.
Initiation of study drug infusion will commence with the occurrence of protocol-defined preoperative hypertension (SBP > 160 mmHg) as measured via an indwelling arterial line.
The study drug (clevidipine or placebo) may be administered to treat hypertension until one hour has elapsed, or until induction of anesthesia, whichever occurs first.
The primary endpoint of bailout described (as defined per protocol) as bailout for lack of efficacy, bailout for safety reason or bailout due to treatment failure will be determined during the 30-minute period from study drug initiation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093249
|United States, Alabama|
|Cardio-Thoracic Surgeons, PC|
|Birmingham, Alabama, United States, 35213|
|United States, California|
|St Vincent Medical Center|
|Los Angeles, California, United States, 90057|
|United States, Florida|
|Discovery Alliance - Hudson|
|Hudson, Florida, United States, 34667|
|Discovery Alliance - Sacred Heart Hospital|
|Pensacola, Florida, United States, 32503|
|United States, Georgia|
|Atlanta VA Medical Center|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Berwyn, Illinois, United States, 60402|
|United States, North Carolina|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|The Christ Hospital, The Linder Clinical Trial Center|
|Cincinnati, Ohio, United States, 45219|
|United States, Texas|
|Houston Northwest Medical Center|
|Houston, Texas, United States, 77090|
|Memorial Herman Memorial City Hospital|
|Houston, Texas, United States, 77024|
|Texas Heart Institute|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Swedish Hospital Medical Center|
|Seattle, Washington, United States, 98104-1318|