Résumé
Patients in the intensive care unit (ICU) with unhealthy alcohol use often experience agitation during mechanical ventilation, which can contribute to post-traumatic stress disorder (PTSD). The BACLOREA trial investigated whether high-dose baclofen could reduce agitation in these patients, but its long-term effects on PTSD symptoms remained unclear. This study aimed to assess whether baclofen administered during ICU stay to reduce the incidence of agitation could reduce the 5-year PTSD symptoms in adult patients with unhealthy alcohol use and improve long-term quality of life and psychological status. This observational follow-up study was conducted between September 2021 and February 2024 and included patients alive five years after participation in the BACLOREA trial, a randomized, placebo-controlled trial evaluating high-dose baclofen for the prevention of agitation-related events during mechanical ventilation in critically ill patients with unhealthy alcohol use. The primary outcome was the prevalence of PTSD symptoms measured using the Impact of Event Scale-Revised (IES-R), with a score ≥ 33 indicating PTSD symptoms. Secondary outcomes included the prevalence of PTSD symptoms using the PTSD Checklist Scale (PCL-S), the quality of life assessed through the SF-36, EQ-5D, and HADS scales. Among the 152 patients who survived five years after ICU admission, 94 (61.8%) completed the follow-up and were included in the BACLO-PTSD study. In this cohort, the 5-year prevalence of PTSD symptoms was 14.9%. For the primary outcome assessed with the IES-R, PTSD symptom prevalence was similar in the baclofen and placebo groups (13.0% vs. 16.7%, p = 0.62). Mean IES-R scores were 10.4 ± 12.5 in the baclofen group and 12.2 ± 13.5 in the placebo group (p = 0.49), while mean PCL-S scores were 25.4 ± 8.6 and 25.5 ± 7.0, respectively (p = 0.94). Quality of life and psychological status, assessed using the SF-36, EQ-5D, and HADS, were also comparable between groups. High-dose baclofen administered during mechanical ventilation did not reduce the 5-year prevalence of PTSD symptoms, nor did it impact quality of life or symptoms of anxiety and depression. Further research is needed to explore alternative strategies for preventing long-term psychological consequences in this population.Trial registration : NCT05877807, 03 april 2023, retrospectively registered.