Modafinil for Wakefulness in the Critical Care Units

NCT04751227 | Completed FDA Drug

• 1 other identifier: RAC # 2201230
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; COVID-19; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• adverse drug reactions (ADRs)

  until ICU discharge, 90 days or death whichever occurs first.

• 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)

  until ICU discharge, 90 days or death whichever occurs first.

• Hospital Length of Stay (LOS)

  until hospital discharge, 90 days or death whichever occurs first.

• Mortality rate

  28 days and 90 days

Study Arms (1)

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

Interventions

Modafinil DRUG

100-200 mg oral daily for for Wakefulness in the Critical Care Units

1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Critical Illness; COVID-19; Cognitive Dysfunction

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marwa R Amer, PharmD, BCPS,BCCCP

  KFSHRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU clinical Pharmacist, Adjunct Assistance professor- college of medicine Alfaisal university

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 12, 2021
• Study Start: November 22, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

SA (1)