Study of Clevidipine Assessing Its Preoperative Antihyper... | NCT00093249

ID	Type	Description	Link
ESCAPE-1	Other Identifier	Sponsor

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clevidipine	Experimental	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.	Drug: clevidipine
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.	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clevidipine	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of bailout during 30-minute treatment period	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	During the first 30 minutes post study drug initiation

Secondary Outcomes

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

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Cardio-Thoracic Surgeons, PC		Birmingham	Alabama	35213	United States
St Vincent Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17898366	Result	Levy JH, Mancao MY, Gitter R, Kereiakes DJ, Grigore AM, Aronson S, Newman MF. Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1. Anesth Analg. 2007 Oct;105(4):918-25, table of contents. doi: 10.1213/01.ane.0000281443.13712.b9.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases