NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Mean change in neuron-specific enolase (NSE)
研究概览
简要总结
This single-center proof of concept study aims to assess the efficacy of a blood pressure strategy targeting person- and time-specific cerebral blood flow compared with standard-of-care using neuron-specific enolase as a quantitative biomarker of brain injury. Our central hypothesis is that an individualized blood pressure strategy targeting cerebral perfusion will reduce the extent of brain injury as indicated by changes in levels of neuron-specific enolase from baseline at 72 hours. To test this hypothesis, we will recruit 49 patients to an individualized blood pressure management strategy targeting cerebral blood flow, where optimal blood pressure will be serially calculated by the ICM+ brain monitoring software (Cambridge, UK) using inputs from transcranial Doppler ultrasound and near-infrared spectroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Comatose defined as not being able to obey verbal commands and no verbal response to pain after sustained ROSC.
排除标准
- •≥ 80 years old at time of enrolment
- •Pregnant patients
- •Limitations of care or life support therapy withdrawn within 24 hours of admission
结局指标
主要结局
Mean change in neuron-specific enolase (NSE)
时间窗: 72 hours post ROSC
The mean change in concentration of NSE from baseline levels to 72 hours post-ROSC.
次要结局
- Peak concentration of renal injury biomarker - Tissue inhibitor of metalloproteinases 2 (TIMP2)(Within 72hours of ROSC)
- Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT)(Within 72hours of ROSC)
- Peak concentration of renal injury biomarker - Insulin Like Growth Factor Binding Protein 7 (IGFBP7)(Within 72hours of ROSC)
- Physical function(Through study completion, average of 12 months post OHCA)
- Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP)(Within 72hours of ROSC)
- Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM)(Within 72hours of ROSC)
- Neuropsychological outcome - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Through study completion, average of 12 months post OHCA)
- Health-related quality of life(Through study completion, average of 12 months post OHCA)
- Peak concentration of renal function - Creatinine(Within 72hours of ROSC)
- Neurological outcome(Through study completion, average of 12 months post OHCA)
- Neuropsychological outcome- Depression, Anxiety, and Stress Scale (DASS-21)(Through study completion, average of 12 months post OHCA)
- Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID)(Within 72hours of ROSC)
- Neurocognitive outcome - Montreal Cognitive Assessment (MOCA)(Through study completion, average of 12 months post OHCA)