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

NCT02003794 | Terminated Phase 3 DMC

• 1 other identifier: IVIS 001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke; intravenous fluid; ้hydration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• mRS ≤ 1

  day 7 after treatment or on the day of discharge

• mRS ≤ 4

  at day 90

• mRS ≤ 1

  at day 90

• change of serum osmolarity

  at day 3 after treatment

Study Arms (2)

IV Fluid

EXPERIMENTAL

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

Drug: 0.9% NaCl solution

No IV Fluid

NO INTERVENTION

Not receive any intravenous fluid but can consume oral fluid normally for three days.

Interventions

0.9% NaCl solution DRUG

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

Also known as: Normal saline

IV Fluid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18-80 years
• NIHSS ≥ 1
• Diagnosis of acute ischemic stroke within 72 hours from stroke onset
• Enrollment into the study within 24 hours after hospital arrival
• Urine specific gravity level \< 1.030
• Patient consent

You may not qualify if:

• Patients receiving \> 40 ml/hr IV fluid infusion over 3 hours
• Acute ischemic stroke caused cardiogenic embolism
• Urine specific gravity ≥ 1.030
• Large cerebral infarction area
• Infarction \> 1/3 of middle cerebral artery area
• Infarction \> 1/2 of cerebellar hemisphere
• NHISS ≥ 18
• Previous or current episode of atrial fibrillation
• Previous or current episode congestive heart failure
• Previous echocardiogram with ejection fraction \< 40%
• Previous or current episode of dilated cardiomyopathy
• Abnormal renal function GFR ≤ 60% or serum creatinine ≥ 2
• Modified Rankin scale before acute ischemic stroke ≥ 2
• Patients receiving intravenous thrombolysis
• NPO with need for IV fluid

Sponsors & Collaborators

• Chulalongkorn University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nijasri C Suwanwela, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Neurology, Department of Medicine, Faculty of Medicine

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 6, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

TH (1)