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临床试验/NCT04412850
NCT04412850Unknown早期 1 期

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

Dow University of Health Sciences0 个研究点目标入组 44 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
44
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Magnesium Sulfate (Drug)

placebo group

Placebo Comparator

Normal Saline in equal volume as the control group.

干预措施: Magnesium Sulfate (Drug)

结局指标

主要结局

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.

时间窗: 7 days

次要结局

  • adverse effects(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huda Naim

Principal Investigator

Dow University of Health Sciences

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