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

Terminated

Phase 3 Results N/A

Trial Description

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.

Trial Stopped: More progressive stroke in one arm

Conditions

Interventions

  • 0.9% NaCl solution Drug
    Other Names: Normal saline
    Intervention Desc: 0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.
    ARM 1: Kind: Experimental
    Label: IV Fluid
    Description: 0.9% NaCl solution infusion: 100 ml/hr for three days.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary NIHSS ≤ 4 day 7 after treatment or on the day of discharge No
Secondary mRS ≤ 1 day 7 after treatment or on the day of discharge No
Secondary mRS ≤ 4 at day 90 No
Secondary change of serum osmolarity at day 3 after treatment No

Sponsors