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

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

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: 0.9% NaCl solution

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV Fluid; 0.9% NaCl solution infusion: 100 ml/hr for three days.	Drug: 0.9% NaCl solution; 0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.; Other Names: Normal saline
No Intervention: No IV Fluid; Not receive any intravenous fluid but can consume oral fluid normally for three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
mRS ≤ 4	Patients with mRS ≤ 4 at day 90	at day 90
mRS ≤ 1	Patients with mRS ≤ 1 at day 90	at day 90
change of serum osmolarity	Percentage of change of serum osmolarity at day 3 after treatment	at day 3 after treatment

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: National Research Council of Thailand
• Investigators: Principal Investigator: Nijasri C Suwanwela, MD, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: August 2, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: acute ischemic stroke; intravenous fluid; ้hydration
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: IVIS 001