The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured PatientsLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Phase 4
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
- Between 18 years and 125 years
- Both males and females
This is an open-label, single arm, single center study in patients with hypertension in the setting of an acute brain injury. Approximately 15 patients admitted to the Columbia University Neurocritical Care Unit with intracerebral hemorrhage, subarachnoid hemorrhage or traumatic brain injury who are...
This is an open-label, single arm, single center study in patients with hypertension in the setting of an acute brain injury. Approximately 15 patients admitted to the Columbia University Neurocritical Care Unit with intracerebral hemorrhage, subarachnoid hemorrhage or traumatic brain injury who are hypertensive and have neuromonitoring probes placed in the course of standard clinical management will be enrolled over a 10-12 month period. Patients must be hypertensive (SBP > 180mmHg), or have an elevated cerebral perfusion pressure (CPP) above 100 mm Hg and the decision has been made by the ICU team to initiate an infusion of clevidipine to maintain CPP within a target range of 70-90 mm Hg and SBP between 120-180mmHg. Due to the decreased level of consciousness from their injury, the majority of patients will be unable to provide consent. Informed consent will be sought from a surrogate according to Columbia University Medical Center (CUMC) guidelines (See section 8-Informed Consent Process). Clevidipine infusion will be used to treat hypertension within the first 24 hours after injury. Multi-modality brain monitoring will have been placed as standard care. Clevidipine will be infused at an initial rate of 2.0 mg/h for the first 90 seconds and titrated to effect (CPP target range of 70-90 mm Hg) by either doubling or reducing the dose by 50% every 90 seconds (with dose ranging 0-32mg/h of continuous IV infusion). At the end of 6 hours clevidipine treatment, the treating physician will make a determination to continue clinical management with clevidipine or change to another antihypertensive medication. Patients will be monitored at 24 hours after infusion for liver function, triglycerides and lipase.
- NCT #
- The Medicines Company
- Principal Investigator: Stephan A Mayer, MD Columbia University