NCT04224246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2023

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

January 7, 2020

Last Update Submit

February 18, 2025

Conditions

Weaning from Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

One arm with Gamma-OH® treatment

EXPERIMENTAL

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.

Drug: Gamma Hydroxybutyrate

Interventions

Gamma HydroxybutyrateDRUG

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

One arm with Gamma-OH® treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • neuromuscular disease
  • central nervous disease
  • psychiatric disease
  • severe obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, Poitiers, 86000, France

Location

MeSH Terms

Interventions

Sodium Oxybate

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 13, 2020

Study Start

February 27, 2020

Primary Completion

February 9, 2023

Study Completion

February 9, 2023

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations

FR(1)