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Intravenous Magnesium Sulphate in Acute Ischemic Stroke

Primary Purpose

Stroke, Ischemic Stroke

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Magnesium Sulfate
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults with a confirmed diagnosis of ischemic stroke on neurological examination and CT scan findings aged between 45 -95 years of age of either gender.
  • Adults presenting within a stroke onset of 24 hours.

Exclusion Criteria:

  • Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial bleed or space occupying lesion)

    • Subjects with systolic blood pressure less than 90mmHg
    • Presence of Bundle Branch block or atrioventricular block.
    • Serum Creatinine > 3mg/dl
    • Respiratory failure (O2 saturation <90% or Respiratory Rate >24 or <12)
    • Pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Control group

    placebo group

    Arm Description

    Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect.

    Normal Saline in equal volume as the control group.

    Outcomes

    Primary Outcome Measures

    Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.

    Secondary Outcome Measures

    adverse effects

    Full Information

    First Posted
    May 11, 2020
    Last Updated
    June 1, 2020
    Sponsor
    Dow University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04412850
    Brief Title
    Intravenous Magnesium Sulphate in Acute Ischemic Stroke
    Official Title
    Role of Intravenous Magnesium Sulphate in Improving Clinical Outcome in Patients Suffering From Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    August 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dow University of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH Stroke Scale (NIHSS) in patients with acute ischemic stroke.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Experimental
    Arm Description
    Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect.
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Normal Saline in equal volume as the control group.
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium Sulfate
    Intervention Description
    Magnesium and placebo (Normal Saline) will be prepared as solutions of identical volume and appearance. All patients will be randomized and blind to treatment. All patients will have pretreatment Electrogram (ECG), serum biochemistry and serum Magnesium levels. Serum Magnesium levels will also be measured at 48 hours. Blood pressure, heart rate, respiratory rate and serious adverse events will be monitored at baseline, 15 minutes, and 12, 24 and 48 hours after infusion. Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. Follow-up visits will be conducted by the same investigators, and repeated scores on the NIH Stroke Scale will be obtained at 24 hours, 48 hours post admission and on the day of discharge.
    Primary Outcome Measure Information:
    Title
    Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    adverse effects
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults with a confirmed diagnosis of ischemic stroke on neurological examination and CT scan findings aged between 45 -95 years of age of either gender. Adults presenting within a stroke onset of 24 hours. Exclusion Criteria: Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial bleed or space occupying lesion) Subjects with systolic blood pressure less than 90mmHg Presence of Bundle Branch block or atrioventricular block. Serum Creatinine > 3mg/dl Respiratory failure (O2 saturation <90% or Respiratory Rate >24 or <12) Pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Huda Naim, MBBS
    Phone
    03333656270
    Email
    huda_naim@live.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intravenous Magnesium Sulphate in Acute Ischemic Stroke

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