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Bolus of Saline in Stroke

NCT01971463 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-12-04

Study results available
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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

Interventions

OTHER

Normal saline

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971463 on ClinicalTrials.gov