IV Double and Triple Concentrated Nicardipine for Stroke and ICH
Status unconfirmed · Phase 4
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT00325793
- Run by
- OSF Healthcare System
- People needed
- 50
- Starts
- 2004-01-01
- Last updated by the study team
- 2006-05-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- OSF Stroke Center — Peoria, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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