IV Double and Triple Concentrated Nicardipine for Stroke and ICH
Recruitment status was Recruiting
|First Received Date ICMJE||May 12, 2006|
|Last Updated Date||May 12, 2006|
|Start Date ICMJE||January 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||• Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||IV Double and Triple Concentrated Nicardipine for Stroke and ICH|
|Official Title ICMJE||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|
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.
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Nicardipine|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00325793|
|Other Study ID Numbers ICMJE||0012003|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||OSF Healthcare System|
|Collaborators ICMJE||PDL BioPharma, Inc.|
|Information Provided By||OSF Healthcare System|
|Verification Date||May 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP