NCT03015584已完成不适用
Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hayling Sentence Completion test
研究概览
简要总结
This study will use systems biology techniques, especially RNA-seq, to understand cognitive impairment after sepsis requiring an intensive care unit (ICU) admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（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
- •Onset of sepsis or septic shock >24 hours after hospital admission
- •Patients transferred from another hospital except for directly from an emergency room
- •Patients transferred to the ICU >48 hours after admission to Intermountain Medical Center (must have been admitted with diagnosis of sepsis)
- •Prior traumatic brain injury, stroke, or intracranial hemorrhage
- •DNR/DNI order before study enrollment
- •Primary diagnosis of stroke or intracranial hemorrhage
- •Known preexisting dementia or substantial cognitive impairment of any cause (established from both chart review, report and/or score ≥3 on IQ Code screening.
- •Prior cardiac surgery (coronary artery bypass grafting or surgical valve replacement or repair)
- •Known schizophrenia or other psychotic thought disorder
- •Known pregnancy
- •Primary diagnosis of drug overdose
- •Attending physician deems aggressive care unsuitable
- •Enrolled in another study if that study involves drug interventions
- •Not expected to survive 48 hours
- •Has a terminal condition independent of the acute illness that is expected to lead to death within 6 months
结局指标
主要结局
Hayling Sentence Completion test
时间窗: 6 months
Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.
次要结局
- Wechsler Memory Scale Logical Memory 2 assessment(6 months)
- Digit Span memory assessment(6 months)
- Wechsler Memory Scale Logical Memory 1 assessment(6 months)
- Verbal Fluency test(6 months)
- Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)(6 months)
- Wechsler Similarities assessment(6 months)
- EuroQol five dimensions questionnaire (EQ-5D-3L)(6 months)
- 36-item short form survey (SF-36)(6 months)
- Impact of Event Scale-Revised (IES-R)(6 months)
- Functional Assessment of Chronic Illness Therapy (FACIT)(6 months)
- Hospital Anxiety and Depression Scale (HADS)(6 months)
- Functional Performance Inventory (FPI)(6 months)
- Hayling Sentence Completion test(3 months)
研究者
Samuel Brown
Director of Center for Humanizing Critical Care; Assistant Director of Critical Care Echocardiography Service, Intermountain Medical Center
Intermountain Health Care, Inc.
研究点 (1)
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