Bolus of Saline in Stroke
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 110 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
Optical Measurement of Cerebral Blood Flow Response After Ischemic Stroke
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.
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.
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
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael T Mullen, MD
Phone: 215-349-8651
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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