We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(More progressive stroke in one arm)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02003794
First Posted: December 6, 2013
Last Update Posted: August 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Research Council of Thailand
Information provided by (Responsible Party):
Nijasri C Suwanwela, Chulalongkorn University
  Purpose
To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.

Condition Intervention Phase
Ischemic Stroke Drug: 0.9% NaCl solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)

Further study details as provided by Nijasri C Suwanwela, Chulalongkorn University:

Primary Outcome Measures:
  • NIHSS ≤ 4 [ Time Frame: 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 Outcome Measures:
  • mRS ≤ 1 [ Time Frame: 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 [ Time Frame: at day 90 ]
    Patients with mRS ≤ 4 at day 90

  • mRS ≤ 1 [ Time Frame: at day 90 ]
    Patients with mRS ≤ 1 at day 90

  • change of serum osmolarity [ Time Frame: at day 3 after treatment ]
    Percentage of change of serum osmolarity at day 3 after treatment


Estimated Enrollment: 120
Study Start Date: May 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Normal saline
No Intervention: No IV Fluid
Not receive any intravenous fluid but can consume oral fluid normally for three days.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003794


Locations
Thailand
Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
National Research Council of Thailand
Investigators
Principal Investigator: Nijasri C Suwanwela, MD Chulalongkorn University
  More Information

Responsible Party: Nijasri C Suwanwela, Division of Neurology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02003794     History of Changes
Other Study ID Numbers: IVIS 001
First Submitted: December 3, 2013
First Posted: December 6, 2013
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Nijasri C Suwanwela, Chulalongkorn University:
acute ischemic stroke
intravenous fluid
้hydration

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Pharmaceutical Solutions


To Top