Modafinil for Wakefulness in the Critical Care Units

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751227
• Other study ID #: RAC # 2201230
• Status: Completed
• Start date: November 22, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: February 2021
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• COVID-19
• Critical Illness

Intervention

Drug:
• Modafinil
100-200 mg oral daily for for Wakefulness in the Critical Care Units

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital and Research Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median change in of Glasgow Coma Scale (GCS)	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	48 hours before modafinil therapy and 7 days after modafinil therapy
Secondary	adverse drug reactions (ADRs)	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	until ICU discharge, 90 days or death whichever occurs first.
Secondary	Duration of Mechanical Ventilation	To assess whether modafinil can help to shorten the time of being in breathing tube and ventilator (duration of mechanical ventilation )	From Intubation to extubation date and off Mechanical Ventilation or until ICU discharge, death, or 90 days whichever occurs first. ]
Secondary	ICU Length of stay (LOS)	To describe ICU LOS	until ICU discharge, 90 days or death whichever occurs first.
Secondary	Hospital Length of Stay (LOS)	To describe hospital LOS	until hospital discharge, 90 days or death whichever occurs first.
Secondary	Mortality rate	Death that occurs during 28 days and 90 days	28 days and 90 days