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

December 3, 2013
December 3, 2013
May 2013
June 2016   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
Drug: 0.9% NaCl solution
0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.
Other Name: Normal saline
  • Experimental: IV Fluid
    0.9% NaCl solution infusion: 100 ml/hr for three days.
    Intervention: Drug: 0.9% NaCl solution
  • No Intervention: No IV Fluid
    Not receive any intravenous fluid but can consume oral fluid normally for three days.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
July 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Supparat Charnwut, RN 6622564655 fern2_95@yahoo.com
Contact: Aurauma Chutinet, MD 6622564655 aurauma@yahoo.com
Thailand
 
NCT02003794
IVIS 001
Yes
Nijasri C Suwanwela, Chulalongkorn University
Chulalongkorn University
National Research Council of Thailand (NRCT)
Principal Investigator: Nijasri C Suwanwela, MD Chulalongkorn University
Chulalongkorn University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP