Intravenous Magnesium Sulphate in Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

Role of Intravenous Magnesium Sulphate in Improving Clinical Outcome in Patients Suffering From Acute Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04412850
• Other study ID #: huda01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: June 2020
• Source: Dow University of Health Sciences
• Contact: Huda Naim, MBBS
• Phone: 03333656270
• Email: huda_naim[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adverse effects		7 days