2023-510212-39-00招募中4 期
Alpha 2 adrenergic receptor agonists for the prevention of delirium and cognitive decline after open heart surgery (ALPHA2PREVENT): randomised controlled trial
Oslo University Hospital HF, Oslo University Hospital HF4 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2024年9月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- Cumulative incidence of postoperative delirium, as diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
研究概览
简要总结
To prevent postoperative delirium
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participant must be ≥70 years old at the time of signing the informed consent.
- •Participant must be accepted for cardiac surgery with cardiopulmonary bypass. The surgical procedures may constitute 1) coronary bypass grafting, 2) tricuspid, mitral, or aortic valve replacement or repair, 3) surgery on the ascending aorta, and 4) the combination of any of these procedures.
- •Participant must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Preoperative delirium (present at time of potential inclusion)
- •Reduced peripheral autonomous activity (e.g. spinal cord injury)
- •Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
- •Endocarditis or sepsis
- •Pheochromocytoma
- •Planned deep hypothermia and circulatory arrest
- •Emergency surgery, defined as less than 24 hours from admission to surgery
- •Previously included in this study
- •Not speaking or reading Norwegian
- •Any other condition as evaluated by the treating physician
- •Known hypersensitivity to the active ingredient or components of the product
- •Bradycardia due to sick-sinus-syndrome, 2nd or 3rd degree AV-block (if not treated with pacemaker) or any other reason causing HR <50 bpm at time of inclusion
- •Uncontrolled hypotension
- •Ischemic stroke or transitory ischemic attack the last month or critical peripheral ischemia
- •Acute coronary syndrome last 24 hours. Acute coronary syndrome is defined according to international guidelines
- •Left ventricular ejection fraction < 40%
- •Severe renal impairment (estimated GFR < 20 ml/min) or expected requirement for renal replacement therapy
- •Severe hepatic dysfunction (liver enzyme three times the upper limit of normal together with a serum albumin concentration below the normal reference limit
结局指标
主要结局
Cumulative incidence of postoperative delirium, as diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
Cumulative incidence of postoperative delirium, as diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
次要结局
- Incidence of coma or postoperative delirium, as measured by Richmond Agitation Sedation Scale (RASS) and according to DSM-5 criteria
- Incidence of death, coma or postoperative delirium, as described above
- Number of delirium days postoperatively, as diagnosed according to DSM-5 criteria
- Delirium severity, as measured by Confusion Assessment Method for Intensive Care Units-7 (CAM-ICU)-7, Observational Scale of Level of Arousal (OSLA) and RASS
- Motor activity patterns, assessed with body worn accelerometers
- Change in cognitive function between inclusion and after 1 and 6 months, as graded by Montreal Cognitive Assessment (MoCA), 10-words memory task from The Consortium Establish a Registry for Alzheimer's Disease (CERAD), digit span tests, Trail making tests (TMT) A and B, semantic and phonemic verbal fluency, and measured repeatedly preoperatively and 1 and 6 months after surgery.
- Change in patient rated health status between inclusion and after 1 and 6 months, as assessed by the EQ-5D-5L questionnaire preoperatively and 1 and 6 months postoperatively
- Comparison to inclusion of serum concentrations of neurofilament light (NFL) and p-tau181 1, 3 and 5 days postoperatively
- Estimate associations between frailty and the other endpoints, as described above
- Safety and tolerability as determined by the numbers of Adverse Events (AEs), serious AEs (SAEs) and suspected unexpected serious adverse reactions (SUSARs), and vital signs; blood pressure (BP), heart rate (HR), peripheral oxygen saturation (SpO2) postoperatively
- Interaction between preoperative frailty and treatment on delirium and the other endpoints, as described above
- Change in frailty status between inclusion and after 1 and 6 months, as graded by the frailty index (FI) and essential frailty toolset (EFT), and measured repeatedly preoperatively and 1 and 6 months after surgery
- Comparison of change in frailty status between inclusion and after 1 and 6 months (as described above) between patients with or without postoperative delirium.
- Comparison of changes in EEG pattern from preoperatively to postoperatively in patients who do and do not develop delirium.
- Comparison of postoperative EEG in patients who do and do not develop delirium and the association with exposure to dexmedetomidine vs clonidine vs placebo
- Additional biomarkers of neural injury, inflammation or neurotransmission may be explored
研究者
Bjørn Erik Neerland
Scientific
Oslo University Hospital HF
研究点 (4)
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