Status:
WITHDRAWN
The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy
Lead Sponsor:
Mario Ammirati
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring d...
Detailed Description
This is a single-arm, open label safety and dose titration study evaluating the use of Clevidipine to rapidly control elevated blood pressure in patients who have an Intracranial Pressure Monitoring d...
Eligibility Criteria
Inclusion
- Male or female, 18 years or older
- Written informed consent from the patient or their legal representative family member before initiation of any study-related procedures
- Patients who clinically require Intracranial Pressure Monitoring device
- Patients who have baseline systolic blood pressure (SBP) (immediately prior to initiation of Clevidipine) \> 160 mmHg measured using an arterial line
- Patients who required IV antihypertensive therapy to achieve SBP ≤ 160 mm Hg
Exclusion
- Patients who are prisoners
- Patients who received an oral antihypertensive medication within 2 hours prior to initiation of Clevidipine
- Patients who received any other IV antihypertensive medication within 2 hours prior to initiation of Clevidipine
- Patients who have fixed dilated pupils and/or absence of gag and oculo-cephalic brain stem reflexes
- Patients with a history of allergy or intolerance to calcium channel blockers
- Patients with a history of allergy to soybean oil or egg lecithin
- Patients who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to enrollment
- Patients who have acute myocardial infarction (AIM) on presentation
- Patients who have known or suspected aortic dissection
- Females who are pregnant or are breastfeeding
- Patients with a history of liver failure, cirrhosis or pancreatitis
- Patients with a prior directive against advanced life support
- Patients with a history of impaired lipid metabolism
- Patients with a history of severe aortic stenosis
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01910532
Start Date
April 1 2010
End Date
November 1 2012
Last Update
July 29 2013
Active Locations (1)
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1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210