Impact of Gamma-OH on Sleep in ICU Patients

GHB

Brief Summary

The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.

Intervention / Treatment

Gamma Hydroxybutyrate (DRUG)

Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours

Condition or Disease

Weaning From Mechanical Ventilation

Phase

Phase 2

Study Design

Study type:	INTERVENTIONAL
Status:	Unknown status
Study results:	No Results Available
Age:	18 Years and older (Adult, Older Adult)
Enrollment:	20 (ESTIMATED)
Funded by:	Other
Allocation:	N/A
Primary Purpose:	Treatment
Masking

Clinical Trial Dates

Start date:	Jan 01, 2020	ESTIMATED
Primary Completion:	Dec 01, 2021	ESTIMATED
Completion Date:	Dec 01, 2021	ESTIMATED
Study First Posted:	Jan 13, 2020	ACTUAL
Results First Posted:	Aug 30, 2020
Last Updated:	Jan 08, 2020

Sponsors / Collaborators

Lead Sponsor: Poitiers University Hospital

Lead sponsor is responsible party

Responsible Party: N/A

Location

Poitiers, Nouvelle-Aquitaine, France

Participant Groups

Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours between 10 p.m. to 4 a.m.

Eligibility Criteria

Sex:	All
Minimum Age:	18
Age Groups:	Adult / Older Adult
Healthy Volunteers:	Yes

Inclusion Criteria:

* intubated at least 24 hours
* difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial.
* Patients will be included after to obtain inform consent.

Exclusion Criteria:

* neuromuscular disease
* central nervous disease
* psychiatric disease
* severe obesity

Primary Outcomes

Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.

More Details

NCT Number:	NCT04224246
Acronym:	GO-SLEEP
Other IDs:	GO-SLEEP
Study URL:	https://clinicaltrials.gov/study/NCT04224246

Last updated: Sep 29, 2023