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Clinical Trials/NCT07762144
NCT07762144Enrolling By InvitationNot Applicable

Clinical Cohort Construction Program of Peking University Third Hospital

Peking University Third Hospital1 site in 1 country500 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
500
Locations
1
Primary Endpoint
Whether death has occurred

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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).

Outcomes

Primary Outcomes

Whether death has occurred

Time Frame: 1 year

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

Secondary Outcomes

  • Assessment of neurological prognosis(1year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Qingbian Ma, MD

Director of the Emergency Department, Peking University Third Hospital

Peking University Third Hospital

Study Sites (1)

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