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

Chulalongkorn University

Status and phase: Terminated; Phase 3

Conditions: Ischemic Stroke

Treatments: Drug: 0.9% NaCl solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02003794

IVIS 001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

IV Fluid

Experimental group

Description:

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

Treatment:

Drug: 0.9% NaCl solution

No IV Fluid

No Intervention group

Description:

Not receive any intravenous fluid but can consume oral fluid normally for three days.