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| ID | Type | Description | Link |
|---|---|---|---|
| ESCAPE-2 |
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The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative 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 placebo.
The primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment groups during the 30-minute time period from initiation of study drug. Secondary objectives included assessments of efficacy through measuring time to target blood pressure (BP) lowering effect defined as 15% reduction in SBP, change in mean arterial pressure (MAP) and the incidence of bailout by causality. Assessments for safety included change in heart rate (HR) from baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clevidipine | Experimental | 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. |
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| placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clevidipine | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bailout during 30-minute treatment period | The incidence of bailout defined as the premature and permanent discontinuation of study drug categorized according to the following reasons:
| During the first 30 minutes post study drug initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to target SBP lowering effect (defined as a reduction by 15% or more) | During the first 30 minutes post study drug initiation | |
| Mean arterial pressure (MAP) change from baseline | During the first 30 minutes post study drug initiation |
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Pre-randomization Inclusion Criteria:
Pre-randomization Exclusion Criteria:
Post-randomization Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discovery Alliance - Mobile Infirmary Medical Center | Mobile | Alabama | 36602 | United States | ||
| Keck School of Medicine, University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18635468 | Result | 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. |
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| Drug |
|
| Heart rate change from baseline | During the first 30 minutes post study drug initiation |
| Incidence of bailout by causality | During the first 30 minutes post study drug initiation |
| Los Angeles |
| California |
| 90033 |
| United States |
| Huntington Memorial Hospital | Pasadena | California | 91109 | United States |
| Stanford University School of Medicine | Stanford | California | 94305-5640 | United States |
| Emory Hospital | Atlanta | Georgia | 30322 | United States |
| Heart Care Research Foundation | Blue Island | Illinois | 60406 | United States |
| MacNeal Hospital | Glencoe | Illinois | 60022 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| St. Lukes Hospital | Kansas City | Missouri | 64111 | United States |
| International Heart Institute | Missoula | Montana | 59802 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029-6574 | United States |
| Columbia University - College of Physicians and Surgeons | New York | New York | 10032 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin VAMC - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C118563 | clevidipine |
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