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NCT05877807 | Recruiting | Alcoholism

Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Sponsor:

Nantes University Hospital

Brief Summary:

Considering the results of the Baclorea study (10% reduction in episodes of agitation in intensive care in the Baclofen group), the investigators would like to know whether this reduction in agitation also results in a reduction in the incidence of the syndrome of long-term post-traumatic stress (5 years later). The investigators wish to contact by telephone, blinded from the randomization group as defined in the framework of the Balorea project, by telephone contact, the patients who had been included in the Balorea study between June 2016 and February 2019.

Condition or disease

Alcoholism

Post Traumatic Stress Disorder

Intervention/treatment

Baclofen

Placebo

Detailed Description:

Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The specific complication of alcoholism in the Intesive care is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complication is agitation. The Baclorea Randomized controlled Study showed that Baclofen significantly reduced the incidence of agitation in ICU but increased the length of stay in ICU. The BACLO-PTSD Study aims at assessing whether Baclofen administered during ICU stay to reduce the incidence of agitation could also reduce the incidence of Post-Traumatic Stress Disorder (PTSD) in mean term compared to placebo Methods/Design: This prospective, randomized, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients included in the BACLO-REA Trial will have to respond to standardized questionnaires to detect Post-Traumatic Stress Disorder (Primary outcome) and to assess quality of life (Secondary outcome). Discussion: Patients will be assessed blind to the randomization group. If patients in the Baclofen group present have a lower incidence of PTSD, the study will suggest that the increase in the length of ICU stay in the baclofen group could be beneficial to reduce the incidence of PTSD in patients with alcohol intake above de NIAAA recommendations.}}

Study Type : Observational
Estimated Enrollment : 314 participants
Official Title : Effect of Baclofen to Prevent Post-Traumatic Stress Disorder: 5 Years Follow-up of the BACLOREA Randomized Trial
Actual Study Start Date : September 3, 2023
Estimated Primary Completion Date : September 3, 2025
Estimated Study Completion Date : September 3, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • All incident patients included in the BACLOREA trial. As a reminder, the criteria were
    • Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research.Non-cerebrodamaged patients admitted to intensive care regardless of the causal pathology with:
    • Consumption of alcohol qualified as "at risk" (For men aged 18 to 64: Consumption ≥ 14 drinks/week in the month preceding hospitalization; For men > 65 and women: Consumption > 7 drinks /week in the month preceding hospitalization).
    • AND Intubated, ventilated with an expected duration of mechanical ventilation of at least 48 hours;
    • AND Aged 18 to 80
    Exclusion Criteria
    • Patients who died during the study or within 5 years of inclusion will not be included. Also, patients who withdrew their consent after inclusion in the Balorea study will not be included. Similarly, patients refusing to answer telephone questionnaires will not be included. Known deceased patients will not be contacted.
    • Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research.
Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

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Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

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Locations

Recruiting

France, Loire Atlantique

Nantes University Hospital

Nantes, Loire Atlantique, France, 44093