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

NCT ID: NCT01910532

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-11-30

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 device.

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 device.

All patients in which ICP monitoring is carried out need to maintain Cerebral Perfusion Pressure (CPP) within a tight range (typically, 70-90 mmHg) in order to avoid secondary brain injuries related to either too high or too low CPP. In this context there are clear benefits associated with a medication that is able to control hypertensive situations quickly and that lends itself to easy and reliable modulation.

Clinical studies have demonstrated that Clevidipine is an effective antihypertensive agent with a rapid onset and offset of action, and a favorable safety profile. Clevidipine has a predictable dose-response profile and is readily titrated to achieve individualized pharmacodynamic effects.

The investigators reasoned that Clevidipine could be an effective anti-hypertensive agent in this cohort of patients in which there is a need for rapid and precise blood pressure control. It is further hypothesized that improved blood pressure control in this patient population may result in the reduction in the severity of their neurological impairment.

The question to be answered is as follows: Is Clevidipine highly effective in achieving and maintaining Blood Pressure control in patients with hypertension (Systolic Blood Pressure > 160 mm Hg) and who require an Intracranial Pressure Monitoring Device?

Clevidipine will be highly effective in achieving and maintaining Blood Pressure control in patients with hypertension and who require an Intracranial Pressure Monitoring Device.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clevidipine

Using Clevidipine for the treatment of acute hypertension defined SBP \> 160 mmHg in patients who require an Intracranial Pressure Monitoring Device

Group Type: EXPERIMENTAL

Clevidipine

Intervention Type: DRUG

Clevidipine for the treatment of acute hypertension defined SBP \> 160 mmHg in patients who require an Intracranial Pressure Monitoring Device

Interventions

Clevidipine

Clevidipine for the treatment of acute hypertension defined SBP \> 160 mmHg in patients who require an Intracranial Pressure Monitoring Device

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Ammirati

OTHER

Sponsor Role: lead

Responsible Party

Mario Ammirati

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mario Ammirati, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2009H0336

Identifier Type: -

Identifier Source: org_study_id