Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)

Study Overview
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Brief Summary
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To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.

Detailed Description
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This study aims to find the effect of early IV fluid administration to patients with acute ischemic stroke on the neurological outcome and to determine the side effects of intravenous fluids. Due to its cost effectiveness and wide accessibility, the possible application or use of IV fluid infusion as first line treatment can aide in the treatment of more acute ischemic stroke patients worldwide. This novel information will aide physicians with more comprehensive understanding of the efficacy of utilizing IV fluid in future treatment plans for patients with acute ischemic stroke.

Official Title
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Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: 0.9% NaCl solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18-80 years NIHSS ≥ 1 Diagnosis of acute ischemic stroke within 72 hours from stroke onset Enrollment into the study within 24 hours after hospital arrival Urine specific gravity level < 1.030 Patient consent Exclusion Criteria: Patients receiving > 40 ml/hr IV fluid infusion over 3 hours Acute ischemic stroke caused cardiogenic embolism Urine specific gravity ≥ 1.030 Large cerebral infarction area Infarction > 1/3 of middle cerebral artery area Infarction > 1/2 of cerebellar hemisphere NHISS ≥ 18 Previous or current episode of atrial fibrillation Previous or current episode congestive heart failure Previous echocardiogram with ejection fraction < 40% Previous or current episode of dilated cardiomyopathy Abnormal renal function GFR ≤ 60% or serum creatinine ≥ 2 Modified Rankin scale before acute ischemic stroke ≥ 2 Patients receiving intravenous thrombolysis NPO with need for IV fluid IV fluid infusion needed from any other causes Patients with poor prognosis with life expectancy < 90 days Patients involved in other ongoing clinical studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Fluid<br>0.9% NaCl solution infusion: 100 ml/hr for three days. | Drug: 0.9% NaCl solution<br>* 0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.<br>* Other names: Normal saline;|
| No Intervention: No IV Fluid<br>Not receive any intravenous fluid but can consume oral fluid normally for three days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS ≤ 4 | Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first. | day 7 after treatment or on the day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS ≤ 1 | Patients with mRS ≤ 1 at day 7 after treatment or on the day of discharge, which ever comes first. | day 7 after treatment or on the day of discharge | 
| mRS ≤ 4 | Patients with mRS ≤ 4 at day 90 | at day 90 | 
| mRS ≤ 1 | Patients with mRS ≤ 1 at day 90 | at day 90 | 
| change of serum osmolarity | Percentage of change of serum osmolarity at day 3 after treatment | at day 3 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, intravenous fluid, ้hydration