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

Primary Purpose

Ischemic Stroke

Status

Terminated

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

0.9% NaCl solution

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring acute ischemic stroke, intravenous fluid, ้hydration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
1. Infarction > 1/3 of middle cerebral artery area
2. 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
IV fluid infusion needed from any other causes
Patients with poor prognosis with life expectancy < 90 days
Patients involved in other ongoing clinical studies

Sites / Locations

Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IV Fluid

No IV Fluid

Arm Description

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

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

Outcomes

Primary Outcome Measures

NIHSS ≤ 4

Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first.

Secondary Outcome Measures

mRS ≤ 1

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

mRS ≤ 4

Patients with mRS ≤ 4 at day 90

mRS ≤ 1

Patients with mRS ≤ 1 at day 90

change of serum osmolarity

Percentage of change of serum osmolarity at day 3 after treatment

Full Information

NCT ID

NCT02003794

First Posted

December 3, 2013

Last Updated

August 2, 2015

Sponsor

Chulalongkorn University

Collaborators

National Research Council of Thailand

1. Study Identification

Unique Protocol Identification Number

NCT02003794

Brief Title

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

Acronym

IVIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

More progressive stroke in one arm

Study Start Date

May 2013 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

Collaborators

National Research Council of Thailand

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

acute ischemic stroke, intravenous fluid, ้hydration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IV Fluid

Arm Type

Experimental

Arm Description

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

Arm Title

No IV Fluid

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

0.9% NaCl solution

Other Intervention Name(s)

Normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

NIHSS ≤ 4

Description

Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first.

Time Frame

day 7 after treatment or on the day of discharge

Secondary Outcome Measure Information:

Title

mRS ≤ 1

Description

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

Time Frame

day 7 after treatment or on the day of discharge

Title

mRS ≤ 4

Description

Patients with mRS ≤ 4 at day 90

Time Frame

at day 90

Title

mRS ≤ 1

Description

Patients with mRS ≤ 1 at day 90

Time Frame

at day 90

Title

change of serum osmolarity

Description

Percentage of change of serum osmolarity at day 3 after treatment

Time Frame

at day 3 after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 IV fluid infusion needed from any other causes Patients with poor prognosis with life expectancy < 90 days Patients involved in other ongoing clinical studies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nijasri C Suwanwela, MD

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chulalongkorn University

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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