Bolus of Saline in Stroke

NCT ID: NCT01971463

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-09-30

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Normal Saline

intravenous administration of 500cc of 0.9% NaCl over 30 minutes

Group Type: EXPERIMENTAL

Normal saline

Intervention Type: OTHER

intravenous administration of 500cc of 0.9% NaCl over 30 minutes

Interventions

Normal saline

intravenous administration of 500cc of 0.9% NaCl over 30 minutes

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

818577

Identifier Type: -

Identifier Source: org_study_id