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临床试验/NCT07464938
NCT07464938尚未招募不适用

New Tools and Predictive Markers in the Prognosis of Hypoxic-ischemic Encephalopathy Following Cardiac Arrest

Cliniques universitaires Saint-Luc- Université Catholique de Louvain0 个研究点目标入组 50 人开始时间: 2026年3月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Neurological outcome

研究概览

简要总结

Cardiac arrest (CA) remains a major cause of mortality and long-term neurological disability worldwide. Despite advances in resuscitation, many survivors suffer from post-cardiac syndrome encompassing PCAS brain injury (PCABI), due to primary (ischemic) and secondary (reperfusion) injury, myocardial dysfunction, systemic response, and persistent underlying causes. PCABI plays a critical role in this complex condition, which is characterized by ischemia, inflammation, and microvascular dysfunction.Current methods to predict neurological outcomes are limited, leading to challenges in clinical decision-making and the risk of premature withdrawal of life-sustaining therapies. This study aims to improve prognostication in CA patients by integrating advanced serum biomarker profiling with cerebral ultrasound (CU) techniques. The investigators hypothesize that combining these tools with clinical data will enhance the accuracy of neurological outcome predictions and deepen understanding of PCABI pathophysiology. The investigators will prospectively enroll 50 CA patients admitted to the intensive care unit at Cliniques Universitaires Saint-Luc. Serum proteomics will be performed using the Reveal panel from Olink®, which analyzes over 1,000 proteins involved in inflammation and thrombosis implicated in PCABI. Concurrently, cerebral ultrasound will assess optic nerve sheath diameter (ONSD) and cerebral blood flow velocities (CBFV) at multiple time points post-resuscitation (at admission, on day 1-2 and on day 3-5). These non-invasive bedside measurements may serve as early indicators of elevated intracranial pressure and cerebral hemodynamic abnormalities.The primary endpoint is poor neurological outcome at one month, defined by the Cerebral Performance Category (CPC) scale. Statistical analyses will evaluate the prognostic value of biomarkers and ultrasound parameters individually and in combination with established clinical predictors.This multimodal approach promises to refine prognostic accuracy, improve clinical decision-making, and identify novel therapeutic targets. Ultimately, our findings may lead to improved patient outcomes and guide future multicenter studies for validation and clinical implementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18-year-old with OHCA admitted to our hospital receiving routine care.

排除标准

  • Patients transferred from other hospitals for OHCA management
  • Patients with pre-existent neurological disease.

研究组 & 干预措施

Ou-of-Hospital Cardiac Arrest (OHCA) patients

Experimental

干预措施: This study aims to improve prognostication in OHCA patients by integrating advanced serum biomarker profiling with cerebral ultrasound techniques (flow velocities, optic nerve sheath diameter) (Diagnostic Test)

结局指标

主要结局

Neurological outcome

时间窗: Throughout the entire study, approximately during 2 years

The Cerebral Performance Category (CPC) scale assesses neurological outcome after cardiac arrest at 3 months. CPC 1: Good cerebral performance; normal life or mild neurological deficit. CPC 2: Moderate cerebral disability; independent in activities of daily living. CPC 3: Severe cerebral disability; dependent for daily support. CPC 4: Coma or persistent vegetative state. CPC 5: Brain death or death.

次要结局

  • Proteomics-based serum alteration (thrombosis and inflammation panel)(Throughout the entire study, approximately during 2 years)
  • Cerebral ultrasound parameters and outcome prediction(Throughout the entire study, approximately during 2 years)
  • ONSD and neurological outcome(Throughout the entire study, approximately during 2 years)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

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