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

Ischemic Stroke Clinical Trial

— IVIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02003794
• Other study ID #: IVIS 001
• Status: Terminated
• Phase: Phase 3
• First received: December 3, 2013
• Last updated: August 2, 2015
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	mRS = 4	Patients with mRS = 4 at day 90	at day 90	No
Secondary	mRS = 1	Patients with mRS = 1 at day 90	at day 90	No
Secondary	change of serum osmolarity	Percentage of change of serum osmolarity at day 3 after treatment	at day 3 after treatment	No