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临床试验/NCT03873662
NCT03873662终止不适用

Biochemical Makers for Outcome Prognostication After Pediatric out-of Hospital Cardiac Arrest: Observational Cohort Trial

Brno University Hospital1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
4
试验地点
1
主要终点
Pediatric cerebral performance category

研究概览

简要总结

This single-center study will validate serum, imaging and clinical markers to determine outcome of pediatric patients early after Out-of-Hospital cardiac arrest (OHCA). Results are expected to add to the field of postresuscitation care of these children. The validation of markers will provide clinicians with the tools to assess the severity of neurological impairment after hypoxic injury to the brain early after OHCA.

详细描述

Cardiac arrest (CA) is an important cause of mortality and morbidity in pediatric patients. Yearly incidence of CA is 7- 8 cases per 100000 children. Hypoxia is the leading cause of OHCA with up to 1/3 being of respiratory origin, and drowning in ¼ of cases. Up to 2/3 of children admitted to hospitals after OHCA die, with only 16,2% survivors with good neurological outcome. Pediatric cerebral performance category (pCPC) 5, which means persistent coma with patent brainstem reflexes or president vegetative state, or pCPC 6 -brain death is considered a bad outcome in pediatric OHCA survivors.

Early prediction of poor outcome is desirable to avoid futile care and to guide the communication with the relatives of the patient.

There is no published recommendation for the prognostication of outcome of comatose pediatric cardiac arrest survivors. The recommendations for adult patients contains the use of neuron-specific enolase (NSE) and protein S-100B in combination with further predictors in prognosticating the outcome of CA. The remaining problem is to determine a cut-off value, to predict poor outcome (CPC category 5 and 6) with 100% specificity. For this reason, the cut-off values are not included in the recommendations.

Neuron-specific enolase is a glycolytic enzyme localized primarily in the cytoplasma of the neurons. The protein S-100B is a calcium-binding protein specific for the astroglia. Both are sensitive and specific markers for neuronal, respectively astroglial cell death. According to data available in the adult population, serum concentration of NSE and S100B are sensitive and specific markers of traumatic brain injury. High concentration of NSE 3 days after cardiac arrest is a strong predictor of poor outcome. Data regarding the prognostic value of neuronal biomarkers in comatose pediatric CA survivors are scarce.

The aim of the pilot study is to determine the association of the concentration of neuronal biomarkers and the outcome of pediatric CA survivors admitted to the pediatric ICU of the University Hospital Brno. The association will be evaluated individually and in combination with clinical and imaging variables. The basic hypothesis is, that the biochemical, clinical and imaging markers of neurological injury are able to prognosticate poor outcome (pCPC 5-6) with high sensitivity and specificity. The innovation of the study will be the evaluation of the dynamics of serum biomarkers early after CA (first 48 hours).

研究设计

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

入排标准

年龄范围
14 Days 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children between 2 weeks -18 years of age
  • Child who suffered an out of hospital CA: defined as "Cessation of cardiac mechanical activity as confirmed by the absence of signs of circulation. Includes the following rhythms: pulseless electrical activity (PEA), asystole, ventricular tachycardia, and ventricular fibrillation" with the need od chest compressions.
  • Children admitted to the Department of pediatric anesthesia and intensive care
  • Children have vascular access for blood draws as part of their standard of care
  • Children have a pre-CA Pediatric Cerebral Performance Category (PCPC) score of 1- 3.

排除标准

  • Patients with brain injury of other etiologies. (trauma, abscess, tumor, bacterial meningitis)
  • Children with do not resuscitate (DNR) status
  • Pregnancy
  • Metabolic or other disease affecting the brain (eg. refractory epilepsy)

结局指标

主要结局

Pediatric cerebral performance category

时间窗: 3 months from cardiac arrest

To evaluate the serum levels of NSE and S100B during first 7 days of hospitalization to determine poor outcome at 3 months post-CA defined as pCPC 5-6

次要结局

  • Pediatric cerebral performance category(3 months from cardiac arrest)

研究者

发起方
Brno University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petr Štourač, MD

assoc.prof.MD,Ph.D

Brno University Hospital

研究点 (1)

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