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| ID | Type | Description | Link |
|---|---|---|---|
| ECLIPSE-SNP | Other Identifier | Sponsor |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clevidipine | Experimental | 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. |
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| sodium nitroprusside | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clevidipine | Drug |
|
| |
| sodium nitroprusside |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of death, stroke, MI and renal dysfunction | Initiation of study drug infusion through post-operative Day 30 |
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Prerandomization Inclusion Criteria:
Prerandomization Exclusion Criteria:
Postrandomization Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm Lloyd, MD | The Medicines Company - Medical Director, Clinical Operations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Vincents Hospital | Birmingham | Alabama | 35205 | United States | ||
| Brookwood Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18806012 | Result | Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db. |
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| Drug |
|
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Baptist Medical Center, Montclair | Birmingham | Alabama | 35213 | United States |
| Baptist Medical Center, South | Montgomery | Alabama | 36101 | United States |
| Drug Research and Analysis Corporation | Montgomery | Alabama | 36106 | United States |
| Providence Saint Joseph Medical Center | Burbank | California | 91505 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610 | United States |
| Health First Holmes Regional Medical Center | Melbourne | Florida | 32901 | United States |
| Kaiser Permanente | Honolulu | Hawaii | 96817 | United States |
| St. Francis Hospital and Health Center | Blue Island | Illinois | 60406 | United States |
| St. Francis Hospital of Evanston | Evanston | Illinois | 60202 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Touro Infirmary | New Orleans | Louisiana | 70115 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| St. Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Massachussettes General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Saint Lukes Hospital | Duluth | Minnesota | 55805 | United States |
| International Heart Institute/St. Patrick Hospital | Missoula | Montana | 59802 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029-6574 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Jackson-Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| Houston Northwest Medical Center | Houston | Texas | 77090 | United States |
| LDS Hospital | Salt Lake City | Utah | 84112 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | 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 |
| D009599 | Nitroprusside |
| ID | Term |
|---|---|
| D005292 | Ferricyanides |
| D003486 | Cyanides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D006856 | Hydrogen Cyanide |
| D017672 | Nitrogen Compounds |
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