Effect of high-dose baclofen on post-traumatic stress disorder symptoms five years after hospitalization among critically ill patients with unhealthy alcohol use

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.