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Neuroprotective Therapy and Therapeutic Target in Emergency Department

Primary Purpose

Stroke, Dehydration

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
normal saline
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, dehydration, prognosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute stroke

Exclusion Criteria:

  • 1.the time between the onset of neurological symptoms and emergency department presentation are more than 12 hours

    2.required fibrinolytic therapy

    3.required surgical intervention

    4.underline disease including congestive heart failure, chronic renal failure ( Cr>2 mg/dl) , liver cirrhosis, chronic obstructive pulmonary disease

    5. initial systolic blood pressure>200 or diastolic blood pressure > 120 mmHg

    6.initial systolic blood pressure<100 mmHg

    7.oxygen saturation less than 92% ( room air )

    8. require diuretics

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Bun/Cr based hydration

control

Arm Description

receive intravenous normal saline infusion and adjust infusion rate by Bun/Cr followed in the first 72 hours

receive intravenous normal saline infusion as clinician's adjustment

Outcomes

Primary Outcome Measures

rate of stroke in evolution

Secondary Outcome Measures

Full Information

First Posted
May 19, 2014
Last Updated
May 23, 2014
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02143596
Brief Title
Neuroprotective Therapy and Therapeutic Target in Emergency Department
Official Title
Neuroprotective Therapy and Therapeutic Target in Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In previous reports, many predictors of early deterioration after ischemic stroke have been proposed and studied, yet the results remain controversial. For example, several studies have been performed to ascertain whether cerebral or systemic causes are the major determinants of stroke deterioration. The findings, however, have been inconsistent. Measures of overall status and stroke severity (low initial Canadian Stroke Severity score, low initial National Institutes of Health Stroke Scale score, early CT findings of stroke severity, and changes in cerebral blood flow affecting the ischemic penumbra as measured by positron emission tomography and single photon emission computed tomography imaging have been shown to predict early deterioration. Laboratory tests for coagulation markers (fibrinogen, D-dimers), inflammatory markers (increased interleukin-6, decreased interleukin-10), serum glucose at admission, hematocrit and physiological parameters, such as blood pressure (both elevated and decreased), and body temperature have been identified as predictors of early deterioration. In addition, patient medical history (diabetes mellitus, atherosclerosis, chronic heart disease) has also been associated with early stroke deterioration. These differing findings may be due to variations in study design, patient populations, selection and exclusion criteria, and the criteria used for defining early deterioration. A further complication in trying to determine predictors of early deterioration after stroke is that different stroke subtypes may manifest differently in terms of clinical changes before deterioration. In most of the aforementioned studies, no attempt was made to differentiate among stroke subtypes. While others have shown that some proposed markers are statistically significant only for certain stroke subtypes. A predictor of early deterioration that is equally applicable to all stroke subtypes is needed. 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. Monitoring of hydration status would also appear to be critical in these patients. Being able to accurately identify patients at risk for early deterioration following stroke will allow for the design of clinical trials of stroke intervention targeting patients with SIE. The investigators need further tests to confirm if the maintenance of proper hydration improve outcome in patients with a Bun/Cr ratio higher than 15.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dehydration
Keywords
stroke, dehydration, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bun/Cr based hydration
Arm Type
Active Comparator
Arm Description
receive intravenous normal saline infusion and adjust infusion rate by Bun/Cr followed in the first 72 hours
Arm Title
control
Arm Type
No Intervention
Arm Description
receive intravenous normal saline infusion as clinician's adjustment
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
the infusion rate of normal saline is determinated by clinicians according to Bun/Cr ratio followed
Primary Outcome Measure Information:
Title
rate of stroke in evolution
Time Frame
72 hours after admission

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute stroke Exclusion Criteria: 1.the time between the onset of neurological symptoms and emergency department presentation are more than 12 hours 2.required fibrinolytic therapy 3.required surgical intervention 4.underline disease including congestive heart failure, chronic renal failure ( Cr>2 mg/dl) , liver cirrhosis, chronic obstructive pulmonary disease 5. initial systolic blood pressure>200 or diastolic blood pressure > 120 mmHg 6.initial systolic blood pressure<100 mmHg 7.oxygen saturation less than 92% ( room air ) 8. require diuretics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leng C Lin, M.D.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Chiayi
ZIP/Postal Code
613
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20825831
Citation
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.
Results Reference
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PubMed Identifier
10978028
Citation
Tei 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.
Results Reference
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Neuroprotective Therapy and Therapeutic Target in Emergency Department

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