跳至主要内容
临床试验/NCT04751227
NCT04751227已完成不适用

Modafinil for Wakefulness in the Critical Care Units and COVID-19 Patients at a Tertiary Care Saudi Hospital

King Faisal Specialist Hospital & Research Center1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年11月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Median change in of Glasgow Coma Scale (GCS)

研究概览

简要总结

It has been well documented that patients in the intensive care unit (ICU) are susceptible to developing neurocognitive and musculoskeletal complications because of various factors, including the nature of the critical illness, medications, over-sedation, and pain. Neuro-stimulants are used to speed up physical and mental processes through the increase in neurotransmitter, which translates into increase in arousal, wakefulness, attention, memory, mental and motor processing speed. The investigators reviewed the literature and described the clinical characteristics for a case series of adult patients admitted to COVID and non-COVID ICU between January 2017 and June 2020, who received modafinil to promote wakefulness and improve cognition at the King Faisal Specialist Hospital and Research Centre (KFSH&RC) in Riyadh, Saudi Arabia. The secondary goals to describe the change of Glasgow Coma Scale (GCS) before and after the start of modafinil therapy, ICU and hospital length of stay, discharge disposition, adverse drug effects, and mortality rate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ICU patients 18 years and older
  • admitted to COVID and non-COVID units between January 2017 and June 2020
  • ICU stay for at least 48 hours
  • started on modafinil during ICU stay for at least 48 h
  • required ventilatory support.

排除标准

  • Those who did not receive modafinil or received modafinil for indications other than ICU wakefulness

研究组 & 干预措施

1

Modafinil 100-200 mg daily for wakefulness in a cohort of adult patients admitted to our COVID and non-COVID intensive care unit (ICU) between January 2017 and June 2020

干预措施: Modafinil (Drug)

结局指标

主要结局

Median change in of Glasgow Coma Scale (GCS)

时间窗: 48 hours before modafinil therapy and 7 days after modafinil therapy

Describe the median change in Glasgow Coma Scale (GCS) before and after modafinil therapy. The GCS is used to assess and communicate changes in mental status and to measure the duration of coma. The Glasgow Coma Scale is comprised of the individual components, e.g. "eye(4) verbal(5) motor (6)". Glasgow Coma Score is calculated by addition of the total points selected under each component (eye, verbal, motor) score can range from 1 and 15

次要结局

  • Duration of Mechanical Ventilation(From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 90 days whichever occurs first. ])
  • Hospital Length of Stay (LOS)(until hospital discharge, 90 days or death whichever occurs first.)
  • adverse drug reactions (ADRs)(until ICU discharge, 90 days or death whichever occurs first.)
  • ICU Length of stay (LOS)(until ICU discharge, 90 days or death whichever occurs first.)
  • Mortality rate(28 days and 90 days)

研究者

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

MARWA RIDHA AMER

ICU clinical Pharmacist, Adjunct Assistance professor- college of medicine Alfaisal university

King Faisal Specialist Hospital & Research Center

研究点 (1)

Loading locations...

相似试验