Clinical trial NCT02003794: Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
Official title: Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke
intravenous fluid
้hydration
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2013-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: NIHSS ≤ 4
timeFrame: day 7 after treatment or on the day of discharge
Secondary outcomes:
measure: mRS ≤ 1
timeFrame: day 7 after treatment or on the day of discharge
measure: mRS ≤ 4
timeFrame: at day 90
measure: mRS ≤ 1
timeFrame: at day 90
measure: change of serum osmolarity
timeFrame: at day 3 after treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Nijasri C Suwanwela, MD
role: PRINCIPAL_INVESTIGATOR
References: