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
About this trial
This is an interventional treatment trial for Stroke
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.
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
NCT ID
NCT04412850
First Posted
May 11, 2020
Last Updated
June 1, 2020
Sponsor
Dow University of Health Sciences
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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