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

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chulalongkorn University
• Collaborator: National Research Council of Thailand
• Treatments: Pharmaceutical Solutions

Criteria

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