Neuroprotective Therapy and Therapeutic Target in Emergency Department
1 other identifier
interventional
159
1 country
1
Brief Summary
The investigators studied laboratory measurements and previously identified risk factors to identify factors predictors of early deterioration following stroke. A prospective observational study of 196 patients with first-time acute ischemic stroke was performed. Following multivariate analysis, only a Bun/Cr \>15 was independent predictor of SIE. These patients were 3.41-fold more likely to have SIE (P=0.008). The elevated Bun/Cr ratio indicates relative dehydration of the patients. An immediate intervention for such patients should be the maintenance of proper hydration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Nov 2010
Typical duration for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedMay 26, 2014
May 1, 2014
3.1 years
May 19, 2014
May 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of stroke in evolution
72 hours after admission
Study Arms (2)
Bun/Cr based hydration
ACTIVE COMPARATORreceive intravenous normal saline infusion and adjust infusion rate by Bun/Cr followed in the first 72 hours
control
NO INTERVENTIONreceive intravenous normal saline infusion as clinician's adjustment
Interventions
the infusion rate of normal saline is determinated by clinicians according to Bun/Cr ratio followed
Eligibility Criteria
You may qualify if:
- acute stroke
You may not qualify if:
- the time between the onset of neurological symptoms and emergency department presentation are more than 12 hours
- required fibrinolytic therapy
- required surgical intervention
- underline disease including congestive heart failure, chronic renal failure ( Cr\>2 mg/dl) , liver cirrhosis, chronic obstructive pulmonary disease
- \. initial systolic blood pressure\>200 or diastolic blood pressure \> 120 mmHg
- initial systolic blood pressure\<100 mmHg
- oxygen saturation less than 92% ( room air )
- \. require diuretics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Chiayi City, 613, Taiwan
Related Publications (2)
Lin LC, Yang JT, Weng HH, Hsiao CT, Lai SL, Fann WC. Predictors of early clinical deterioration after acute ischemic stroke. Am J Emerg Med. 2011 Jul;29(6):577-81. doi: 10.1016/j.ajem.2009.12.019. Epub 2010 Apr 2.
PMID: 20825831BACKGROUNDTei H, Uchiyama S, Ohara K, Kobayashi M, Uchiyama Y, Fukuzawa M. Deteriorating ischemic stroke in 4 clinical categories classified by the Oxfordshire Community Stroke Project. Stroke. 2000 Sep;31(9):2049-54. doi: 10.1161/01.str.31.9.2049.
PMID: 10978028BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leng C Lin, M.D.
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 21, 2014
Study Start
November 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 26, 2014
Record last verified: 2014-05