Recruiting

Nicardipine

Sponsor:

OSF Healthcare System

Code:

NCT00325793

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nicardipine

Study Details

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.

Conditions

Hypertension

Study ID

NCT00325793

Start date

Jan, 2004

Status verified date

May, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Nicardipine

Primary outcome measure

  • • Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

David Wang, DO

309-624-9500dwang@uic.edu

Locations

OSF Stroke Center

Recruiting

Peoria, Illinois, United States, 61637

Principal Investigator:

David Wang, DO

More Information

Sponsor

OSF Healthcare System

Last update posted

May 15, 2006

Last verified

May, 2006

Keywords

  • nicardipine
  • hypertension
  • intracerebral hemorrhage
  • ischemic stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OSF Healthcare System on 2006-05-15.