NCT01946932已完成不适用
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 287
- 试验地点
- 20
- 主要终点
- Rivermead Behavioural Memory Test (RBMT)
研究概览
简要总结
This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest.
The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction.
Our secondary aims are:
- To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life.
- To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden.
- To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age 18 years or older
- •Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
- •Unconsciousness after sustained return of spontaneous circulation (ROSC)
- •Exclusion Criteria at time for inclusion in the TTM study:
- •Known bleeding diathesis
- •Suspected or confirmed acute intracranial bleeding
- •Suspected or confirmed stroke
- •Unwitnessed asystole
- •Known limitations in therapy and Do Not Resuscitate-order
- •Known disease making 180 days survival unlikely
- •Known prearrest status Cerebral Performance Category (CPC)3 or 4
- •Temperature <30°on admission
- •4 hours (240 minutes) from ROSC to screening
- •Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump
- •In-hospital cardiac arrest
- •OHCA of presumed non-cardiac arrest cause
- •Additional Exclusion criteria for the sub-study:
- •Disability to speak the site language well enough to complete tests without interpreter
- •Controls should never have suffered a cardiac arrest
排除标准
- 未提供
结局指标
主要结局
Rivermead Behavioural Memory Test (RBMT)
时间窗: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)
Memory test
Frontal Assessment Battery (FAB)
时间窗: 180 days after CA or MI
Screening of Executive functions
Symbol Digit Modalities Test (SDMT)
时间窗: 180 days after CA or MI
Assess attention, mental speed and concentration
次要结局
- Mayo-Portland Adaptability Inventory-4 (MPAI-4)(180 days after CA or MI)
- Short-Form Questionnaire 36 version 2 (SF-36v2)(180 days after CA or MI)
- Zarit Burden Interview(180 days after CA or MI)
- Hospital Anxiety and Depression rating Scale (HADS)(180 days after CA or MI)
- Two Simple Questions (TSQ)(180 days after CA or MI)
- Informant Questionnaire on Cognitive Decline (IQCODE)(180 days after CA or MI)
- MiniMental Status Examination (MMSE)(180 days after CA or MI)
- Cerebral Performance Category (CPC)(180 days after CA or MI)
- modified Rankin Scale(180 days after CA or MI)
研究者
研究点 (20)
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