Modafinil for Wakefulness in the Critical Care Units

Completed

• Conditions: Critical Illness; COVID-19; Cognitive Dysfunction
• Interventions: Drug: Modafinil

• Registration Number: NCT04751227
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-22
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-12
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Modafinil	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

Primary Outcome Measures

Name	Time	Method
Median change in of Glasgow Coma Scale (GCS)	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

Secondary Outcome Measures

Name	Time	Method
Duration of Mechanical Ventilation	From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 90 days whichever occurs first. ]	To assess whether modafinil can help to shorten the time of being in breathing tube and ventilator (duration of mechanical ventilation )
Hospital Length of Stay (LOS)	until hospital discharge, 90 days or death whichever occurs first.	To describe hospital LOS
adverse drug reactions (ADRs)	until ICU discharge, 90 days or death whichever occurs first.	Number of patients started on antipsychotics and with possible adverse drug reactions (ADRs) related to modafinil including nervousness, agitation, delirium, hypersensitivity, and drug rash. Naranjo scale was used to evaluate the causality of ADRs and modafinil therapy
ICU Length of stay (LOS)	until ICU discharge, 90 days or death whichever occurs first.	To describe ICU LOS
Mortality rate	28 days and 90 days	Death that occurs during 28 days and 90 days

Trial Locations

Locations (1)

King Faisal Specialist Hospital and Research Center; 🇸🇦 Riyadh, Saudi Arabia