Intravenous Magnesium Sulphate in Acute Ischemic Stroke

NCT04412850 | Unknown Early Phase 1

• 1 other identifier: huda01
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (1)

• adverse effects

  7 days

Study Arms (2)

Control group

EXPERIMENTAL

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.

Drug: Magnesium Sulfate

placebo group

PLACEBO COMPARATOR

Normal Saline in equal volume as the control group.

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

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.

Control group; placebo group

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Huda Naim, MBBS

CONTACT

03333656270; huda_naim@live.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 2, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share