Critically Ill Clinical Trial
— GASWACOfficial title:
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient.
Verified date | August 2022 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 31, 2022 |
Est. primary completion date | June 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Ramathibodi Hospital, Mahidol University | Ratchathewi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Arttawejkul P, Reutrakul S, Muntham D, Chirakalwasan N. Effect of Nighttime Earplugs and Eye Masks on Sleep Quality in Intensive Care Unit Patients. Indian J Crit Care Med. 2020 Jan;24(1):6-10. doi: 10.5005/jp-journals-10071-23321. — View Citation
Carrera-Hernández L, Aizpitarte-Pejenaute E, Zugazagoitia-Ciarrusta N, Goñi-Viguria R. Patients' perceptions of sleep in a Critical Care Unit. Enferm Intensiva (Engl Ed). 2018 Apr - Jun;29(2):53-63. doi: 10.1016/j.enfi.2018.01.002. Epub 2018 Mar 28. Engli — View Citation
Devlin JW, Skrobik Y, Gélinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299. — View Citation
Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. — View Citation
Liu GJ, Karim MR, Xu LL, Wang SL, Yang C, Ding L, Wang YF. Efficacy and Tolerability of Gabapentin in Adults with Sleep Disturbance in Medical Illness: A Systematic Review and Meta-analysis. Front Neurol. 2017 Jul 14;8:316. doi: 10.3389/fneur.2017.00316. — View Citation
Lo HS, Yang CM, Lo HG, Lee CY, Ting H, Tzang BS. Treatment effects of gabapentin for primary insomnia. Clin Neuropharmacol. 2010 Mar-Apr;33(2):84-90. doi: 10.1097/WNF.0b013e3181cda242. — View Citation
Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advanc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | IGF-1 | IGF-1 level | At day 0, 1, 3, and 5 after randomization | |
Primary | Slow-wave sleep | Slow-wave sleep period or deep sleep period | at least 3 consecutive days after randomization | |
Secondary | All-cause hospital mortality | Rates of all-cause mortality during hospital stay | During hospital stay or death or a maximum of 90 days | |
Secondary | ICU free days | Days alive and not stay in ICU | During ICU stay or death or a maximum of 28 days | |
Secondary | Mechanical ventilator free days | Day alive and free of mechanical ventilator | During ICU stay or death or a maximum of 28 days | |
Secondary | Hospital free days | Days alive and not stay in hospital | During hospital stay or death or a maximum of 90 days | |
Secondary | Incidence of self-extubation | Number of patients who had self-extubation during ICU stay | During ICU stay or death or a maximum of 28 days | |
Secondary | Incidence of sleep deprivation | Times per patient-days of sleep deprivation during ICU stay | During ICU stay or death or a maximum of 28 days | |
Secondary | Delirium free day | Days alive and not having delirium | During ICU stay or death or a maximum of 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05539521 -
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation
|
Phase 2 | |
Recruiting |
NCT04776486 -
Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance
|
N/A | |
Completed |
NCT05766319 -
The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission
|
N/A | |
Recruiting |
NCT03231540 -
The PREServation of MUScle Function in Critically Ill Patients (PRESMUS)
|
N/A | |
Completed |
NCT02286869 -
Cardioventilatory Coupling in Critically Ill Patients
|
N/A | |
Completed |
NCT01434823 -
24 Hour Intensivist Coverage in the Medical Intensive Care Unit
|
N/A | |
Active, not recruiting |
NCT01142570 -
Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
|
N/A | |
Completed |
NCT01167595 -
Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients
|
N/A | |
Completed |
NCT01293708 -
Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:
|
||
Not yet recruiting |
NCT00916591 -
Prokinetic Drugs and Enteral Nutrition
|
N/A | |
Recruiting |
NCT00654797 -
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2
|
Phase 2 | |
Withdrawn |
NCT00178321 -
Improving Sleep in the Pediatric Intensive Care Unit
|
N/A | |
Completed |
NCT01168128 -
PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study
|
N/A | |
Completed |
NCT02447692 -
Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study
|
N/A | |
Recruiting |
NCT04582760 -
Early Mobilization in Ventilated sEpsis & Acute Respiratory Failure Study
|
N/A | |
Not yet recruiting |
NCT05961631 -
Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation
|
||
Completed |
NCT03276650 -
Admission of Adult-onset Still Disease Patients in the ICU
|
||
Completed |
NCT03922113 -
Muscle Function After Intensive Care
|
||
Recruiting |
NCT05055830 -
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
|
||
Recruiting |
NCT06027008 -
Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults
|
N/A |