Effect of Baclofen to Prevent Post-Traumatic Stress Disorder: 5 Years Follow-up of the BACLOREA Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 13
- 主要终点
- Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental : BACLOFEN
Patient will receive baclofen caps
干预措施: Baclofen (Drug)
Placebo Comparator : PLACEBO
Patient will receive placebo caps (lactose)
干预措施: Placebo (Other)
结局指标
主要结局
Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R)
时间窗: 5 years post hospitalization
It has 2 important dimensions for the diagnosis of post-traumatic stress disorder: repetitive memories and persistent avoidance. The questionnaire is composed of 22 items to which the patient must respond using a scale of 0 to 4 (0 = not at all / 1 = a little / 2 = moderately / 3 = good-fair / 4 = extremely). Incidence of Post traumatic stress disorder defined by a score greater or equal to 33.
次要结局
- Assessment of patient Habits(5 years post hospitalization)
- Evaluation of the quality of life using the questionnaire European Quality of Life-5 Dimensions (EQ-5D)(5 years post hospitalization)
- Screen for anxiety and depressive disorders with Hospital Anxiety and Depression scale (HAD Quiz)(5 years post hospitalization)
- Evaluation of the Posttraumatic stress disorder (PCL-S Quiz)(5 years post hospitalization)
- Health assessement with the Short Form (SF-36 Quiz)(5 years post hospitalization)