Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
NCT ID: NCT02003794
Last Updated: 2015-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
120 participants
INTERVENTIONAL
2013-05-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IV Fluid
0.9% NaCl solution infusion: 100 ml/hr for three days.
0.9% NaCl solution
0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.
No IV Fluid
Not receive any intravenous fluid but can consume oral fluid normally for three days.
No interventions assigned to this group
Interventions
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0.9% NaCl solution
0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. NIHSS ≥ 1
3. Diagnosis of acute ischemic stroke within 72 hours from stroke onset
4. Enrollment into the study within 24 hours after hospital arrival
5. Urine specific gravity level \< 1.030
6. Patient consent
Exclusion Criteria
2. Acute ischemic stroke caused cardiogenic embolism
3. Urine specific gravity ≥ 1.030
4. Large cerebral infarction area
1. Infarction \> 1/3 of middle cerebral artery area
2. Infarction \> 1/2 of cerebellar hemisphere
5. NHISS ≥ 18
6. Previous or current episode of atrial fibrillation
7. Previous or current episode congestive heart failure
8. Previous echocardiogram with ejection fraction \< 40%
9. Previous or current episode of dilated cardiomyopathy
10. Abnormal renal function GFR ≤ 60% or serum creatinine ≥ 2
11. Modified Rankin scale before acute ischemic stroke ≥ 2
12. Patients receiving intravenous thrombolysis
13. NPO with need for IV fluid
14. IV fluid infusion needed from any other causes
15. Patients with poor prognosis with life expectancy \< 90 days
16. Patients involved in other ongoing clinical studies
18 Years
80 Years
ALL
No
Sponsors
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National Research Council of Thailand
OTHER_GOV
Chulalongkorn University
OTHER
Responsible Party
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Nijasri C Suwanwela
Division of Neurology, Department of Medicine, Faculty of Medicine
Principal Investigators
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Nijasri C Suwanwela, MD
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
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Chulalongkorn University
Bangkok, Bangkok, Thailand
Countries
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Other Identifiers
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IVIS 001
Identifier Type: -
Identifier Source: org_study_id
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