The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy

• Status: Withdrawn
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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 device.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Ammirati
• Treatments: Antihypertensive Agents; Clevidipine

Criteria

Inclusion Criteria:

1. Male or female, 18 years or older

2. Written informed consent from the patient or their legal representative family member before initiation of any study-related procedures

3. Patients who clinically require Intracranial Pressure Monitoring device

4. Patients who have baseline systolic blood pressure (SBP) (immediately prior to initiation of Clevidipine) > 160 mmHg measured using an arterial line

5. Patients who required IV antihypertensive therapy to achieve SBP ≤ 160 mm Hg

Exclusion Criteria:

1. Patients who are prisoners

2. Patients who received an oral antihypertensive medication within 2 hours prior to initiation of Clevidipine

3. Patients who received any other IV antihypertensive medication within 2 hours prior to initiation of Clevidipine

4. Patients who have fixed dilated pupils and/or absence of gag and oculo-cephalic brain stem reflexes

5. Patients with a history of allergy or intolerance to calcium channel blockers

6. Patients with a history of allergy to soybean oil or egg lecithin

7. Patients who have participated or are currently participating in a clinical trial of an investigational drug within 30 days prior to enrollment

8. Patients who have acute myocardial infarction (AIM) on presentation

9. Patients who have known or suspected aortic dissection

10. Females who are pregnant or are breastfeeding

11. Patients with a history of liver failure, cirrhosis or pancreatitis

12. Patients with a prior directive against advanced life support

13. Patients with a history of impaired lipid metabolism

14. Patients with a history of severe aortic stenosis