Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

NCT ID: NCT05877807

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-03
• Study Completion Date: 2024-02-28

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.

Conditions

Alcoholism; Post Traumatic Stress Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental : BACLOFEN

Patient will receive baclofen caps

Baclofen

Intervention Type: DRUG

Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the treatment will be administered via the nasogastric feeding tube. After extubation, the treatment will be administered either via the nasogastric tube or the oral route.

Placebo Comparator : PLACEBO

Patient will receive placebo caps (lactose)

Placebo

Intervention Type: OTHER

Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the placebo will be administered via the nasogastric feeding tube. After extubation, the placebo will be administered either via the nasogastric tube or the oral route.

Interventions

Baclofen

Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the treatment will be administered via the nasogastric feeding tube. After extubation, the treatment will be administered either via the nasogastric tube or the oral route.

Intervention Type: DRUG

Placebo

Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the placebo will be administered via the nasogastric feeding tube. After extubation, the placebo will be administered either via the nasogastric tube or the oral route.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim ASEHNOUNE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Brest University Hospital

Brest, Finistère, France

Cornouaille Hospital

Quimper, Finistère, France

Montpellier University Hospital

Montpellier, Hérault, France

Rennes University Hospital

Rennes, Ile-et-Vilaine, France

Tours University Hospital

Tours, Indre-et-Loire, France

Nantes University Hospital

Nantes, Loire-Atlantique, France

Saint-Nazaire Hospital

Saint-Nazaire, Loire-Atlantique, France

Angers University Hospital

Angers, Maine-et-Loire, France

South Bretagne Hospital Center

Lorient, Morbihan, France

Le Mans University Hospital

Le Mans, Sarthe, France

Vendee Departmental Hospital

La Roche-sur-Yon, Vendee, France

Poitiers University Hospital

Poitiers, Vienne, France

Saint-Antoine Hospital (AP-HP)

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

RC21_0251

Identifier Type: -

Identifier Source: org_study_id