Modafinil for Wakefulness in the Critical Care Units

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Critical Illness; Cognitive Dysfunction
• Intervention / Treatment: Drug: Modafinil

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Faisal Specialist Hospital and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID ICU and non-COVID ICU units (medical, surgical, transplant/oncology ICUs).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Modafinil; 100-200 mg oral daily for for Wakefulness in the Critical Care Units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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. ]
ICU Length of stay (LOS)	To describe ICU LOS	until ICU discharge, 90 days or death whichever occurs first.
Hospital Length of Stay (LOS)	To describe hospital LOS	until hospital discharge, 90 days or death whichever occurs first.
Mortality rate	Death that occurs during 28 days and 90 days	28 days and 90 days

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Marwa R Amer, PharmD, BCPS,BCCCP, KFSHRC

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurocognitive Disorders; Disease Attributes; Cognition Disorders; COVID-19; Cognitive Dysfunction; Critical Illness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: RAC # 2201230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No