Clinical trial NCT05877807: Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Official title: Effect of Baclofen to Prevent Post-Traumatic Stress Disorder: 5 Years Follow-up of the BACLOREA Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholism
Post Traumatic Stress Disorder
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who took part in the Baclorea study between 2016 and 2019. This study assessed the benefit of treatment with baclofen for the prevention of agitation in intensive care during the period of mechanical ventilation.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R)
timeFrame: 5 years post hospitalization
Secondary outcomes:
measure: Evaluation of the quality of life using the questionnaire European Quality of Life-5 Dimensions (EQ-5D)
timeFrame: 5 years post hospitalization
measure: Health assessement with the Short Form (SF-36 Quiz)
timeFrame: 5 years post hospitalization
measure: Screen for anxiety and depressive disorders with Hospital Anxiety and Depression scale (HAD Quiz)
timeFrame: 5 years post hospitalization
measure: Evaluation of the Posttraumatic stress disorder (PCL-S Quiz)
timeFrame: 5 years post hospitalization
measure: Assessment of patient Habits
timeFrame: 5 years post hospitalization
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
state: Finistère
city: Quimper
country: France
facility: Cornouaille Hospital
state: Finistère
city: Montpellier
country: France
facility: Montpellier University Hospital
state: Hérault
city: Paris
country: France
facility: Saint-Antoine Hospital (AP-HP)
state: Ile-de-France
city: Rennes
country: France
facility: Rennes University Hospital
state: Ile-et-Vilaine
city: Tours
country: France
facility: Tours University Hospital
state: Indre-et-Loire
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
city: Saint-Nazaire
country: France
facility: Saint-Nazaire Hospital
state: Loire-Atlantique
city: Angers
country: France
facility: Angers University Hospital
state: Maine-et-Loire
city: Lorient
country: France
facility: South Bretagne Hospital Center
state: Morbihan
city: Le Mans
country: France
facility: Le Mans University Hospital
state: Sarthe
city: La Roche-sur-Yon
country: France
facility: Vendee Departmental Hospital
state: Vendee
city: Poitiers
country: France
facility: Poitiers University Hospital
state: Vienne
Study officials:
affiliation: Nantes University Hospital
name: Karim ASEHNOUNE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: