Modafinil for Wakefulness in the Critical Care Units

NCT ID: NCT04751227

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-22

Study Completion Date

2021-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness COVID-19 Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Modafinil

Intervention Type DRUG

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

Interventions

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Modafinil

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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MARWA RIDHA AMER

ICU clinical Pharmacist, Adjunct Assistance professor- college of medicine Alfaisal university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa R Amer, PharmD, BCPS,BCCCP

Role: PRINCIPAL_INVESTIGATOR

KFSHRC

Locations

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King Faisal Specialist Hospital and Research Center

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RAC # 2201230

Identifier Type: -

Identifier Source: org_study_id

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