Bolus of Saline in Stroke

Ischemic Stroke Clinical Trial

— BOSS  

Official title:

Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971463
• Other study ID #: 818577
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Est. completion date: September 2019

Study information

• Verified date: November 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2019
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Normal saline
intravenous administration of 500cc of 0.9% NaCl over 30 minutes

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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