Impact of Gamma-OH on Sleep in ICU Patients

Phase 2

Completed

• Conditions: Weaning from Mechanical Ventilation
• Interventions: Drug: Gamma Hydroxybutyrate

• Registration Number: NCT04224246
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-02-27
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm with Gamma-OH® treatment	Gamma Hydroxybutyrate	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients having poor sleep with Gamma-OH	Hour24	Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®.

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France