Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm: Outpatient Follow-up of Mental Health INDices (SDATE OF MIND)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post-traumatic stress disorder symptoms
研究概览
简要总结
The goal of the research study is to measure mental health and quality of life indices of individuals treated for electrical storm (ES). The consequences of being admitted to an intensive care unit (ICU) with electrical storm as well as the treatments patients would have received, are currently not well understood. Understanding the mental health burden of these treatments among survivors can provide insights into how to improve care.
This is a study consisting of patients who participated in the SEDATE trial (dexmedetomidine vs usual standard of care to treat ES in the ICU). Patients who consent to participate in this study will be asked to complete a set of questionnaires 3-6 months after their ICU admission. The purpose of the questionnaires is to measure indices of mental health and health-related quality of life. Each questionnaire will take about 5-15 minutes to complete.
If patients have a scheduled follow-up at the University of Ottawa Heart Institute, a member of the research team will meet with them during their clinic visit to complete the questionnaires. Otherwise, they can be completed over the telephone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to an intensive care unit with a diagnosis of electrical storm within the preceding 6 months
- •Previous participants in the SEDATE trial (NCT06281977)
排除标准
- 未提供
研究组 & 干预措施
Placebo
Usual standard of care (not including dexmedetomidine) during electrical storm admission
干预措施: Placebo (Drug)
Dexmedetomidine
Treatment with dexmedetomidine during electrical storm admission
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Post-traumatic stress disorder symptoms
时间窗: Assessed 3-6 months after hospitalization for electrical storm
Post-traumatic stress disorder (PTSD) checklist (PCL-5) score. Respondents are asked to rate the presence and severity of various symptoms in the preceding month on 5-point Likert scale. A higher score indicates worse symptoms. A cumulative cut-off score of 31-33 is usually considered indicative of probable PTSD
次要结局
- Anxiety symptoms(Assessed 3-6 months after hospitalization for electrical storm)
- Depression symptoms(Assessed 3-6 months after hospitalization for electrical storm)
- Anxiety/fear relating to implantable cardioverter-defibrillator shocks(Assessed 3-6 months after hospitalization for electrical storm)
- Quality of life measure(Assessed 3-6 months after hospitalization for electrical storm)