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IV Double and Triple Concentrated Nicardipine for Stroke and ICH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00325793
Recruitment Status : Unknown
Verified May 2006 by OSF Healthcare System.
Recruitment status was:  Recruiting
First Posted : May 15, 2006
Last Update Posted : May 15, 2006
Sponsor:
Collaborator:
PDL BioPharma, Inc.
Information provided by:
OSF Healthcare System

Tracking Information
First Submitted Date  ICMJE May 12, 2006
First Posted Date  ICMJE May 15, 2006
Last Update Posted Date May 15, 2006
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2006)
• 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
 (submitted: May 12, 2006)
  • Time and dosage adjustment needed to reach the target BP range
  • Safety
  • To evaluate the tolerance of the double or triple concentrated Nicardipine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Nicardipine
Study Arms  ICMJE 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 Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: May 12, 2006)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325793
Other Study ID Numbers  ICMJE 0012003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE OSF Healthcare System
Collaborators  ICMJE PDL BioPharma, Inc.
Investigators  ICMJE
Principal Investigator: David Wang, DO OSF Stroke Center
PRS Account 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