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临床试验/NCT07762144
NCT07762144Enrolling By Invitation不适用

Clinical Cohort Construction Program of Peking University Third Hospital

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
500
试验地点
1
主要终点
Whether death has occurred

研究概览

简要总结

Cardiac arrest is one of the leading life-threatening emergencies, with approximately 540,000 cases occurring annually in China. Among patients who experience cardiac arrest, active cardiopulmonary resuscitation can achieve return of spontaneous circulation in 40% of cases; however, only 1-2% ultimately survive with favorable neurological outcomes. The primary contributor to mortality and morbidity is post-cardiac arrest syndrome (PCAS). PCAS represents a distinct pathophysiological process resulting from systemic ischemia/reperfusion injury, involving multiple systems and organs, and thus requires comprehensive, systematic evaluation. At present, numerous challenges remain in the field of PCAS, including the optimal targeted temperature, additional interventions that may improve neurological prognosis, post-resuscitation myocardial dysfunction and its protective strategies, characteristics and management of dysfunction in other organs, and accurate neurological prognostication after resuscitation. Therefore, in-depth research on PCAS is urgently needed to improve outcomes in cardiac arrest survivors.

This study is initiated by the Department of Emergency Medicine, Peking University Third Hospital, and involves a total of six tertiary hospitals across China, constituting a multicenter investigation. The study aims to explore the effects of different targeted temperature management strategies on mortality and neurological outcomes, and to actively investigate other interventions that may ameliorate post-resuscitation brain injury, cardiac injury, and microcirculatory dysfunction, thereby reducing mortality and improving neurological prognosis in cardiac arrest patients. Furthermore, we aim to develop a neurological prediction model for cardiac arrest patients to enable accurate prognostication of neurological outcomes, which will assist emergency physicians in providing precise prognostic information to families and facilitate shared decision-making regarding subsequent treatment plans.

详细描述

For patients with cardiac arrest, brain injury is the leading cause of mortality and disability, followed by cardiac dysfunction and microcirculatory disorders. Therefore, post-resuscitation cerebral protection, myocardial protection, and the prevention and treatment of microcirculatory failure are key to the management of post-cardiac arrest syndrome (PCAS). This cohort study aims to observe exposure factors related to the cardiopulmonary resuscitation (CPR) process and the subsequent treatment of post-resuscitation syndrome, in order to explore the factors contributing to the low quality of CPR in China and to provide evidence for improving prehospital emergency care. Simultaneously, it aims to investigate exposure factors during in-hospital treatment and to identify effective interventions for improving brain function, cardiac function, and microcirculatory dysfunction.

③ Prognostic factor exploration and prognostic model establishment (may be broken down into multiple sub-questions).

For patients with cardiac arrest, neurological assessment, i.e., the evaluation of the severity of brain injury, represents both a major challenge and a key priority in the field of CPR, and it remains a current research hotspot. Accurate neurological assessment can prevent premature withdrawal of life-sustaining therapy in patients with potential for cerebral recovery-early withdrawal being a primary cause of death in cardiac arrest patients in the ICU. Conversely, it also enables early identification of patients without hope of neurological recovery, thereby providing families with more accurate prognostic information, facilitating shared decision-making regarding subsequent treatment, and reasonably optimizing the utilization of medical resources. The objective of this cohort is to establish a predictive model for mortality and poor neurological outcomes in patients with cardiac arrest, based on multimodal data incorporating clinical assessments, imaging, neuroelectrophysiology, and biomarkers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have achieved return of spontaneous circulation (ROSC) after cardiac arrest;
  • With accessible intravenous or intraosseous vascular access;
  • Clinical manifestations meeting any one of the following criteria: presenting with post-resuscitation brain injury, post-resuscitation cardiac dysfunction, manifestations of systemic ischemia-reperfusion injury, or other ongoing deteriorating pathological changes.

排除标准

  • Patients who have not achieved return of spontaneous circulation (ROSC) after cardiac arrest;
  • Patients who have declined cardiopulmonary resuscitation (CPR) (or whose legally authorized representative has refused CPR).

结局指标

主要结局

Whether death has occurred

时间窗: 1 year

Death: any death, regardless of cause (i.e., all-cause mortality)

次要结局

  • Assessment of neurological prognosis(1year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qingbian Ma, MD

Director of the Emergency Department, Peking University Third Hospital

Peking University Third Hospital

研究点 (1)

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