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

• ClinicalTrials.gov Identifier: NCT01910532
• Recruitment Status: Withdrawn
• First Posted: July 29, 2013
• Last Update Posted: July 29, 2013
• Sponsor: Mario Ammirati
• Information provided by (Responsible Party): Mario Ammirati, Ohio State University

Tracking Information

• First Submitted Date: December 19, 2011
• First Posted Date: July 29, 2013
• Last Update Posted Date: July 29, 2013
• Study Start Date: April 2010
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2013)

Time to achieve target Systolic Blood Pressure within 30 minutes of start of Celevidipine infusion [ Time Frame: Up to 1 year ]

To evaluate the efficacy of Clevidipine for the treatment of acute hypertension during the first 30 minutes after initiation of the intravenous infusion in patients who require an Intracranial Pressure Monitoring Device

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 25, 2013)

• Percentage of patients who reach target Systolic Blood Pressure within 30 minutes of start of Clevidipine infusion [ Time Frame: Up to 1 year ]
  To evaluate the efficacy of Clevidipine to maintain Systolic Blood Pressure (SBP) within the target range after the first 30 minutes of an initial infusion and up to 3 hours in patients who required an Intracranial Pressure Monitoring
• Percentage of patients in who the Systolic Blood Pressure is maintained within the target range for up to 3 hours after the first 30 minutes of the start of Clevidipine infusion [ Time Frame: Up to 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy
• Official Title: The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

Drug: Clevidipine

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

Study Arms

Experimental: Clevidipine

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

Intervention: Drug: Clevidipine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 25, 2013): 0
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2012
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01910532
• Other Study ID Numbers: 2009H0336
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mario Ammirati, Ohio State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mario Ammirati
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mario Ammirati, MD; Ohio State University

• PRS Account: Ohio State University
• Verification Date: July 2013