Impact of Gamma-OH on Sleep in ICU Patients

Weaning From Mechanical Ventilation Clinical Trial

— GO-SLEEP  

Official title:

Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean From Mechanical Ventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04224246
• Other study ID #: GO-SLEEP
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weaning From Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients having poor sleep with Gamma-OH	Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.	Hour24