IV Double and Triple Concentrated Nicardipine for Stroke and ICH
Information source: OSF Healthcare System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Nicardipine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: OSF Healthcare System Official(s) and/or principal investigator(s): David Wang, DO, Principal Investigator, Affiliation: OSF Stroke Center
Overall contact: David Wang, DO, Phone: 309-624-9500, Email: dwang@uic.edu
Summary
Hypertension (high blood pressure) can often cause neurological worsening in patients with
stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of
nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of
Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The
purpose of this study is to evaluate safety and efficacy of double or triple concentrated
peripheral intravenous (IV) Nicardipine.
Clinical Details
Official title: An Open-Label Prospective Study to Evaluate the Safety and Efficacy of Double or Triple Concentrated Intravenous Nicardipine for Treatment of Hypertension in Patients With Ischemic Stroke, Intracerebral Hemorrhage or Subarachnoid Hemorrhage
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: • Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit.
Secondary outcome: Time and dosage adjustment needed to reach the target BP rangeSafety To evaluate the tolerance of the double or triple concentrated Nicardipine
Detailed description:
Hypertension can often cause neurological worsening in patients with either ICH or SAH.
Hypertension has been related to increased incidence of intracranial hemorrhage in patients
who are treated with thrombolytics or on anticoagulation. Timely control of hypertension is
directly related to the outcome of these patients. Furthermore, unlike in the conditions of
hypertensive emergency or urgency, gentle titration to control the blood pressure is
recommended in patients with either ischemic cerebral infarction or hemorrhage. Therefore
the ideal agent to control hypertension in these patients would have these characteristics:
- Rapid onset of action
- Predictable dose response
- Titratable to desired BP
- Minimal dosage adjustments
- Minimal adverse effects
- No increase in INTRACRANIAL PRESSURE (ICP)
- Easy transition to oral formulation for long-term maintenance
Currently, only IV sodium nitroprusside, nitroglycerine, enalapril and esmolol are used for
controlling blood pressure in patients with IS, ICH and SAH. These agents are difficult to
titrate and may potentially be harmful to brain cells.
Nicardipine offers several advantages in blood pressure control. It may cause dilatation of
the coronary vessels while has no effect on cardiac conduction. It is not associated with
coronary steal. As the only IV calcium channel blocker approved for the treatment of
hypertension, nicardipine is vasoselective, and has a rapid onset and precisely controllable
in a variety of patient types. It is as effective as sodium nitroprusside with fewer dose
adjustments. It has documented safety with a low incidence of side effects. It requires
minimal dose adjustments.
The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to
150 cc/hr). In patients with ischemic cerebral stroke (IS) or hemorrhage (ICH), intravenous
infusion of large volume can contribute to cerebral edema or increase in intracranial
pressure (ICP). If the infusion of nicardipine can be double or triple concentrated without
the need of a central line, it not only offers titratable BP control, but also less overall
volume to infuse the drug.
This is a phase IV prospective, open-label, dose regimen study of double or triple
concentration nicardipine infusion for controlling blood pressure in patients with either
ischemic cerebral infarction (IS) or intracerebral hemorrhage (ICH) or subarachnoid
hemorrhage (SAH). Once the patient has the need for rapid control of blood pressure, he or
she will be eligible for the study. The first 25 patients will be consented for the double
dose treatment and the next 25 patients will be consented for the triple dose treatment. The
patient will be followed during the infusion period for efficacy and safety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females, 18 years of age or older.
- Acute ischemic cerebral stroke (IS) with uncontrollable hypertension that may need to
be controlled for the purpose of considering thrombolytic therapy or anticoagulation
therapy.
- Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage
(SAH) (surgically treated or not), any territory with an appropriate study (head CT
scan or MRI scan) providing results consistent with this diagnosis, who may require
the control of hypertension or control of blood pressure.
Exclusion Criteria:
- Allergy to Nicardipine or known hypersensitivity to Nicardipine.
- Chronic renal failure or Creatinine blood sample levels> 2. 0.
- Impaired hepatic function defined as a two times value of liver enzymes.
- Severe left ventricular dysfunction defined as ventricular ejection fraction < 30%.
- Patients or authorized representative who refused be enrolled into this study.
- Advanced aortic stenosis.
- Pregnant or nursing women will not be enrolled in this study.
- No patient will be allowed to be enrolled in this study more than once.
- Patients may not be enrolled into other clinical studies during their involvement
with this study.
Locations and Contacts
David Wang, DO, Phone: 309-624-9500, Email: dwang@uic.edu
OSF Stroke Center, Peoria, Illinois 61637, United States; Recruiting David Wang, DO, Principal Investigator
Additional Information
Starting date: January 2004
Last updated: May 12, 2006
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