Induced Hypertension for Acute Ischemic Stroke

Completed

Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- 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.

Exclusion Criteria

- 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.