Clinical trial
Effect of Baclofen to Prevent Post-Traumatic Stress Disorder: 5 Years Follow-up of the BACLOREA Randomized Trial
Name
RC21_0251
Description
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.
Trial arms
Trial start
2023-09-03
Estimated PCD
2025-09-03
Trial end
2025-09-03
Status
Recruiting
Treatment
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.
Arms:
Experimental : BACLOFEN
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.
Arms:
Placebo Comparator : PLACEBO
Size
314
Primary endpoint
Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R)
5 years post hospitalization
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 314, 'type': 'ESTIMATED'}}
Updated at
2023-10-30
1 organization
1 product
2 indications
Organization
Nantes University HospitalProduct
BaclofenIndication
Alcohol use disorderIndication
Post-Traumatic Stress Disorder