Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT01910532
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01910532
Study Brief:
Protocol Section:
NCT01910532