Impact of Gamma-OH on Sleep in ICU Patients

NCT ID: NCT04224246

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2023-02-09

Brief Summary

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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

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Conditions

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Weaning from Mechanical Ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One arm with Gamma-OH® treatment

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.

Group Type EXPERIMENTAL

Gamma Hydroxybutyrate

Intervention Type DRUG

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

Interventions

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Gamma Hydroxybutyrate

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Poitiers

Poitiers, Poitiers, France

Site Status

Countries

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France

Other Identifiers

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GO-SLEEP

Identifier Type: -

Identifier Source: org_study_id

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