Critical IllnessNCT04751227
Modafinil for Wakefulness in the Critical Care Units
An observational study of Critical Illness and COVID-19, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness, COVID-19, Cognitive Dysfunction
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 22 Nov 2020to 30 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: COVID ICU and non-COVID ICU units (medical, surgical, transplant/oncology ICUs).
Who may be able to join
- 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.
Who cannot join
- Those who did not receive modafinil or received modafinil for indications other than ICU wakefulness
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Center
Riyadh
About this study
Official title: 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.
- Conditions
- Critical Illness, COVID-19, Cognitive Dysfunction
- Being tested
- Modafinil
- Medical subject headings
- Critical Illness, COVID-19, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
100-200 mg oral daily for for Wakefulness in the Critical Care Units
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours before modafinil therapy and 7 days after modafinil therapy
Secondary outcomes (5)
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
Measured: 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 )
Measured: 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
Measured: until ICU discharge, 90 days or death whichever occurs first.
Hospital Length of Stay (LOS)
To describe hospital LOS
Measured: until hospital discharge, 90 days or death whichever occurs first.
Mortality rate
Death that occurs during 28 days and 90 days
Measured: 28 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start22 Nov 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARWA RIDHA AMER, King Faisal Specialist Hospital & Research Center
- Investigators
- Marwa R Amer, PharmD, BCPS,BCCCP, Principal investigator, KFSHRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751227
- Sponsor's protocol ID
- RAC # 2201230
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil for Wakefulness in the Critical Care Units and COVID-19 Patients at a Tertiary Care Saudi Hospital
- ClinicalTrials.gov ID
- NCT04751227
- Acronym / sponsor ID
- RAC # 2201230
- Conditions
- Critical Illness, COVID-19, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 22 Nov 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: ModafinilModafinil 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID ICU and non-COVID ICU units (medical, surgical, transplant/oncology ICUs).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who did not receive modafinil or received modafinil for indications other than ICU wakefulness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinil100-200 mg oral daily for for Wakefulness in the Critical Care Units | Drug | 1 |
Primary outcome
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
5 secondary outcomes
adverse drug reactions (ADRs)
Time frame: until ICU discharge, 90 days or death whichever occurs first.
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. ]
ICU Length of stay (LOS)
Time frame: until ICU discharge, 90 days or death whichever occurs first.
Hospital Length of Stay (LOS)
Time frame: until hospital discharge, 90 days or death whichever occurs first.
Mortality rate
Time frame: 28 days and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa R Amer, PharmD, BCPS,BCCCP principal investigator
KFSHRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and COVID-19, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median change in of Glasgow Coma Scale (GCS) (time frame: 48 hours before modafinil therapy and 7 days after modafinil therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.