Impact of Gamma-OH on Sleep in ICU Patients (GO-SLEEP)

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: Weaning from Mechanical Ventilation

Treatments: Drug: Gamma Hydroxybutyrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04224246

GO-SLEEP

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

One arm with Gamma-OH® treatment

Experimental group

Description:

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.

Treatment:

Drug: Gamma Hydroxybutyrate