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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-01-31

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.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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IV Fluid

0.9% NaCl solution infusion: 100 ml/hr for three days.

Group Type EXPERIMENTAL

0.9% NaCl solution

Intervention Type DRUG

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.

Group Type NO_INTERVENTION

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.

Intervention Type DRUG

Other Intervention Names

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Normal saline

Eligibility Criteria

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Inclusion Criteria

1. Age from 18-80 years
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

1. Patients receiving \> 40 ml/hr IV fluid infusion over 3 hours
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Nijasri C Suwanwela

Division of Neurology, Department of Medicine, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Thailand

Other Identifiers

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IVIS 001

Identifier Type: -

Identifier Source: org_study_id

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