The Effect of Clevidipine on Intracranial Pressure and Cerebral Perfusion Pressure (CCP) in Brain Injured Patients
Status:
Withdrawn
Trial end date:
2012-12-19
Target enrollment:
Participant gender:
Summary
Patients with acute brain injury are at risk for complications such as increased pressure in
the brain (intracranial pressure (ICP)), decreased blood flow, bleeding, and brain swelling
(cerebral edema). Several studies have suggested that high blood pressure is associated with
a worsening outcome possibly due to an increased rate of continued bleeding or rebleeding, as
well as increased brain swelling (cerebral edema). High systemic (body) blood pressure (SBP)
may also increase the risk of ongoing bleeding. Therefore lowering the blood pressure (BP) is
critical, as continued bleeding occurs most frequently in patients with high BP.
Clevidipine Butyrate (Cleviprex) is a new medication approved by the FDA for the treatment of
acute high blood pressure (hypertension). Cleviprex is given through an intravenous line (IV)
and has the benefit of being faster acting and easier to control adjustments than other drugs
used to treat high BP. Patients who have an acute brain injury and who have severe high BP
may benefit from this faster acting medication.
For this study, eligible patients, 18 yrs of age or older, will have been admitted to the
Neurocritical care unit within 24 hours after their brain injury, who have high systemic
(body) SBP. The treating physicians will have already had multimodality brain monitoring
placed for clinical management of the patient (standard care).
The investigators will use Cleviprex to lower their SBP and record brain pressure and brain
blood flow measurements from the multimodality monitoring. Due to the severity of their brain
injury most of the patients eligible for the study will be unable to provide consent.
Informed consent will be sought from a surrogate (family member, spouse or close friend)
according to Columbia University Medical Center guidelines.
Cleviprex is fast acting and effects are seen in about 90 seconds. The medication will be
started at a low rate, and if the SBP still needs lowering, the dose increased every 90
seconds until the maximum FDA approved dose is reached. If the SBP is still high, another
medication used to treat high blood pressure will be added (Cardene or labetolol).
Once the SBP is lowered and is stable, the Cleviprex will be continued for 6 hours. As part
of standard care, patients have their blood pressure monitored continuously. After 6 hours
the treating physician will make a determination to continue clinical management with
cleviprex or another antihypertensive medication.