Induced Hypertension for Acute Ischemic Stroke

Completed · Phase 2

Conditions studied: Acute Ischemic Stroke

In brief

The ultimate goal of this multicenter, phase II study is to increase blood pressure until either a neurologic response is seen or a target mean arterial pressure of 30% above baseline is achieved. IV fluids, IV phenylephrine and/or IV norepinephrine are used to rapidly raise mean arterial pressure in a controlled manner as serial assessments of neurologic function are performed.

Key facts

Study ID

NCT00227448

Run by

Johns Hopkins University

People needed

60

Starts

2003-06-01

Expected to finish

2005-04-01

Last updated by the study team

2008-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with acute ischemic stroke in whom treatment can be initiated within 12 hours of a clearly defined symptom onset. (If the patient awakens with a deficit, time of onset is considered the time the patient was last seen functioning normally.)
• Age older then 18 years of age.
• Measurable neurologic deficit other than isolated facial weakness, sensory loss or ataxia. NIHSS must be > 4 points.
• Head CT showing no evidence of intracranial hemorrhage or mass lesion which might increase the risk of bleeding.
• Absence of ischemic changes on EKG (i.e. > than 1mm ST segment elevation or depression in at least two contiguous leads, new T waves inversion in two leads).
• No contraindication to MRI studies, including allergy to gadolinium.

You may not qualify if…

• History of unstable angina, any recent angina (defined as chest pain) in the past 3 months, recent myocardial infarction (less then 3 months), any history of ventricular arrhythmia, presence of left ventricular bundle branch block on EKG.
• History of severe and symptomatic cardiac valvular disease.
• History of congestive heart failure, dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, or known ejection fraction < 25%.
• Systolic blood pressure greater > 200 mm Hg or MAP > 120 mm HG when patient is initially monitored.
• Serum creatinine greater then 2 mg/dl.
• History of symptomatic peripheral vascular disease or Raynaud's syndrome.
• Suspected seizure at the onset of stroke.
• Treatment with IV tPA or other thrombolytic agent.
• Massive stroke (> 2/3 MCA territory) or any amount of midline shift due to cerebral edema on head CT.
• Pregnancy
• Current use of MAO inhibitors, tricyclic antidepressant medications, or cyclopropane or halothane anesthetic agents.
• Coma.
• Allergies or known contraindications to the use of IV phenylephrine, IV norepinephrine, sodium metabisulfite, or oral midodrine.
• Hemorrhage on initial MRI or CT or other structural lesion that might raise the risk of intracranial bleeding.
• Thrombocytopenia (plt < 100 k), PTT > 100 sec, INR > 3.0 at time of treatment.
• Participation in other investigational trial within 30 days.
• Moderate to severe baseline disability (pre-stroke Rankin score of > 3), severe or terminal concurrent medical illness with expected survival of < 3 months, or other concurrent medical or psychiatric condition which may limit neurologic assessment or patient follow-up in the opinion of the investigator.
• Requirement for anticoagulation with IV heparin or warfarin in the first 48 hours after enrollment.
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
• Toxicology screen positive for cocaine.
• Intubated at time of enrollment.
• Mesenteric or peripheral vascular thrombosis.
• Profound hypoxia or hypercarbia as defined as a PaO2 level less than 50 or a PaCO2 level of greater than 60.
• Norepinephrine Exclusion Criteria- The patient will not receive Norepinephrine if the patient has any of the following: lack of sufficient vascular access (central line or peripheral line greater than 18 gauge is sufficient), hypersensitivity to norepinephrine products, severe hypertension as in 4.2.4 above, tachycardia defined as HR >100 for 10 minutes sustained, myocardial infarction, pulmonary edema, peripheral ischemia, or ventricular arrhythmias.

Where it is running

• University of Maryland Medical Systems — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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