Clinical trial NCT04751227: Modafinil for Wakefulness in the Critical Care Units
Official title: Modafinil for Wakefulness in the Critical Care Units and COVID-19 Patients at a Tertiary Care Saudi Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
COVID-19
Cognitive Dysfunction
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID ICU and non-COVID ICU units (medical, surgical, transplant/oncology ICUs).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Median change in of Glasgow Coma Scale (GCS)
timeFrame: 48 hours before modafinil therapy and 7 days after modafinil therapy
Secondary outcomes:
measure: adverse drug reactions (ADRs)
timeFrame: until ICU discharge, 90 days or death whichever occurs first.
measure: Duration of Mechanical Ventilation
timeFrame: From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 90 days whichever occurs first. ]
measure: ICU Length of stay (LOS)
timeFrame: until ICU discharge, 90 days or death whichever occurs first.
measure: Hospital Length of Stay (LOS)
timeFrame: until hospital discharge, 90 days or death whichever occurs first.
measure: Mortality rate
timeFrame: 28 days and 90 days
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center
Study officials:
affiliation: KFSHRC
name: Marwa R Amer, PharmD, BCPS,BCCCP
role: PRINCIPAL_INVESTIGATOR
References: