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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Chulalongkorn University
Sponsor:
Collaborator:
National Research Council of Thailand (NRCT)
Information provided by (Responsible Party):
Nijasri C Suwanwela, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT02003794
First received: December 3, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • NIHSS ≤ 4 [ Time Frame: day 7 after treatment or on the day of discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patients with mRS ≤ 4 at day 90

  • mRS ≤ 1 [ Time Frame: at day 90 ] [ Designated as safety issue: No ]
    Patients with mRS ≤ 1 at day 90

  • change of serum osmolarity [ Time Frame: at day 3 after treatment ] [ Designated as safety issue: No ]
    Percentage of change of serum osmolarity at day 3 after treatment


Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003794

Contacts
Contact: Supparat Charnwut, RN 6622564655 fern2_95@yahoo.com
Contact: Aurauma Chutinet, MD 6622564655 aurauma@yahoo.com

Locations
Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Supparat Charnwut, RN    6622564655    fern2_95@yahoo.com   
Contact: Aurauma Chutinet, MD    6622564655    aurauma@yahoo.com   
Principal Investigator: Nijasri C Suwanwela, MD         
Sponsors and Collaborators
Chulalongkorn University
National Research Council of Thailand (NRCT)
Investigators
Principal Investigator: Nijasri C Suwanwela, MD Chulalongkorn University
  More Information

No publications provided

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
Study First Received: December 3, 2013
Last Updated: December 3, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
acute ischemic stroke
intravenous fluid
้hydration

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

ClinicalTrials.gov processed this record on August 21, 2014