Intravenous Magnesium Sulphate in Acute Ischemic Stroke

NCT ID: NCT04412850

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: EXPERIMENTAL

Magnesium Sulfate

Intervention Type: 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.

placebo group

Normal Saline in equal volume as the control group.

Group Type: PLACEBO_COMPARATOR

Magnesium Sulfate

Intervention Type: 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.

Interventions

Magnesium Sulfate

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Huda Naim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Huda Naim, MBBS

Role: CONTACT

huda_naim@live.com

03333656270

Other Identifiers

huda01

Identifier Type: -

Identifier Source: org_study_id