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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02003794

Acronym

IVIS

Enrollment

120

Registered

2013-12-06

Start date

2013-05-31

Completion date

2015-01-31

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke, intravenous fluid, ้hydration

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.

Interventions

DRUG0.9% NaCl solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
mRS ≤ 1	day 7 after treatment or on the day of discharge	Patients with mRS ≤ 1 at day 7 after treatment or on the day of discharge, which ever comes first.
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026