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Completed

NCT Number: NCT04751227

Modafinil for Wakefulness in the Critical Care Units

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.

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Key information

Conditions

Critical Illness COVID-19 Cognition Disorders Cognitive Dysfunction Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Mental Disorders Neurocognitive Disorders Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Modafinil

Drug

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

Primary outcomes

  1. Median change in of Glasgow Coma Scale (GCS)

    Time frame: 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 outcomes

  1. adverse drug reactions (ADRs)

    Time frame: 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

  2. Duration of Mechanical Ventilation

    Time frame: 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 )

  3. ICU Length of stay (LOS)

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

    To describe ICU LOS

  4. Hospital Length of Stay (LOS)

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

    To describe hospital LOS

  5. Mortality rate

    Time frame: 28 days and 90 days

    Death that occurs during 28 days and 90 days

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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