Bolus of Saline in Stroke

Study Overview
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Brief Summary
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This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke within 96 hours of enrollment. The study intervention will be a one hour monitoring session. There will be a 15 minute baseline measurement period, followed by intravenous administration of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All study measurements will cease after 1 hour. Subjects will be followed during their hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse events and to collect clinical information.

Official Title
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Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery territory on either side of the brain Study intervention can be initiated within 96 hours of symptom onset Willingness and ability to sign informed consent by patient or legally acceptable surrogate decision-maker Exclusion Criteria: Infarct limited to the brainstem and/or cerebellum with no involvement of the cerebral hemispheres Bi-hemispheric infarction or acute infarct in the contra-lateral hemisphere within the past 30 days Symptoms of active congestive heart failure (dyspnea, orthopnea, increased oxygen requirement) Exacerbation of congestive heart failure, requiring hospitalization, within the past 30 days or severe systolic dysfunction with a known ejection fraction <20% End stage renal disease requiring hemodialysis or a creatinine clearance <20 ml/min/1.73 m2 Hemicraniectomy or other skull defect that would interfere with monitoring Pregnant women are excluded. Women of child-bearing age must have a negative pregnancy test prior to enrollment Participation in another clinical trial Any other illness or condition that the investigator feels would pose a hazard to the subject from participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Saline<br>intravenous administration of 500cc of 0.9% NaCl over 30 minutes | Other: Normal saline<br>* intravenous administration of 500cc of 0.9% NaCl over 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | Ipsilesional hemisphere | 30 minutes after completion of saline bolus | 
| The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | contralesional hemisphere | 30 minutes after completion of saline bolus |