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

Phase 3

Terminated

• Conditions: Ischemic Stroke
• Interventions: Drug: 0.9% NaCl solution

• Registration Number: NCT02003794
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-02
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Fluid	0.9% NaCl solution	0.9% NaCl solution infusion: 100 ml/hr for three days.

Primary Outcome Measures

Name	Time	Method
NIHSS ≤ 4	day 7 after treatment or on the day of discharge	Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first.

Secondary Outcome Measures

Name	Time	Method
mRS ≤ 1	at day 90	Patients with mRS ≤ 1 at day 90
mRS ≤ 4	at day 90	Patients with mRS ≤ 4 at day 90
change of serum osmolarity	at day 3 after treatment	Percentage of change of serum osmolarity at day 3 after treatment

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand