Clinical trial NCT04818450: Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient
Official title: Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Critically Ill
Keywords: gabapentin
sleep deprivation
critically ill patients
slow-wave sleep
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators proposed that gabapentin will increase slow-wave sleep in adult critically ill patients. Increasing slow-wave sleep will improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.

Detailed description: Up to 61% of critically ill patients have sleep deprivation in ICU. Sleep deprivation can cause delirium and lead to prolonged ICU length of stay and mechanical ventilator days. However, pharmacologic interventions to improve sleep quality and prevent sleep deprivation are poorly tested for efficacy and safety in ICU patients. There were reports of gabapentin increasing slow-wave sleep in healthy populations and insomnia patients with insignificant adverse events. Therefore, gabapentin might increase slow-wave sleep resulting in improving clinical outcomes in adult critically ill patients. The objectives of the study were to evaluate the efficacy, especially on slow-wave sleep, and safety of gabapentin in adult critically ill patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand.

Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older)
* Patients admitted to ICU not more than 24 hours at the time of randomization

Exclusion Criteria:

* Patients admitted to ICU less than 72 hours
* Patients receiving gabapentin within 14 days prior to randomization
* Patients receiving restorative drug (trazodone, mirtazapine, olanzapine, agomelatine, and pregabalin) within 7 days prior to randomization
* Patients having contraindications to gabapentin
* Patients receiving high dose vasopressors more than 1 hour during ICU admissions
* Patients presenting with severe respiratory failure (PF ratio \< 100)
* Patients presenting with RASS \< -2 at the time of randomization
* Patients having target RASS of \<-2 during ICU admissions
* Terminal ill patients
* Pregnancy

Primary outcomes:
measure: Slow-wave sleep
timeFrame: at least 3 consecutive days after randomization
Secondary outcomes:
measure: All-cause hospital mortality
timeFrame: During hospital stay or death or a maximum of 90 days
measure: ICU free days
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Mechanical ventilator free days
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Hospital free days
timeFrame: During hospital stay or death or a maximum of 90 days
measure: Incidence of self-extubation
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Incidence of sleep deprivation
timeFrame: During ICU stay or death or a maximum of 28 days
measure: Delirium free day
timeFrame: During ICU stay or death or a maximum of 28 days
Other outcomes:
measure: IGF-1
timeFrame: At day 0, 1, 3, and 5 after randomization
Locations:
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Ramathibodi hospital, Mahidol university
name: Yuda Sutherasan, MD
role: STUDY_DIRECTOR
affiliation: Mahidol University
name: Kanyarat Susantitapong, B.Sc.(Pharm)
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Pitchaya Dilokpattanamongkol, BCPS, BCCCP, BCP
role: STUDY_DIRECTOR
affiliation: Mahidol University
name: Chuthamanee Suthisisang, Ph.D.
role: STUDY_CHAIR
affiliation: Piyavate Hospital
name: Viratch Tangsujaritvijit, Ph.D.
role: STUDY_CHAIR
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