Bolus of Saline in Stroke

Phase 2

Completed

• Conditions: Ischemic Stroke
• Interventions: Other: Normal saline

• Registration Number: NCT01971463
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Primary Completion: 2016-09
• Study Completion: 2019-09
• Results First Submitted: 2019-09-30
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-14
• Results First Posted: 2019-12-04
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal saline	intravenous administration of 500cc of 0.9% NaCl over 30 minutes

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States