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临床试验/NCT01987466
NCT01987466Unknown不适用

Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients

Yonsei University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
73
试验地点
1
主要终点
Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest.

研究概览

简要总结

Postresuscitation disease is a constellation of disorders related to whole-body ischemia and reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other organ. In previous study more than one-third of patients resuscitation from out of hospital cardiac arrest developed renal dysfunction. In acute kidney injury, NGAL is an earlier marker compared with serum creatinine.

Cardiac arrest and severe asphyxia result in global brain ischemia. In previous study serum NGAL correlated with hypoxic ischemic encephalopathy in asphyxiated neonate.

This study was designed to assess serum NGAL level in postresuscitative patients to evaluate its relation to hypoxic brain injury severity, and its clinical utility for early detection of acute kidney injury in these patients.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years and older
  • Successful resuscitation from out of hospital cardiac arrest and spontaneous circulation time is longer than 20 min.

排除标准

  • Pre-existing coma before cardiac arrest
  • Mental change with other cause except cardiac arrest.(Ex. traumatic brain injury, cerebro-vascular accident.)
  • Unstable vital sign (Systolic blood pressure is lower than 60mmHg)
  • History of terminal illness.
  • Coagulation deficiency.
  • Pregnancy state or younger than 18 year
  • Pre-existing end-stage renal disease or dependence on renal replacement therapy
  • Transfer to other hospital and cannot know prognosis
  • Withdrawal of care due to family wishes
  • The patient arrives our hospital after 4 hours or longer from resuscitation.
  • The patient refuses to sign the consent

结局指标

主要结局

Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest.

时间窗: Every 4 hour until 72 hour after resuscitation

All patients in this study will be treated by induced hypothermia protocol in our hospital. Plasma NGAL level will check after 4hour from resuscitation. Renal dysfunction is defined using the RIFLE criteria. Patient base line creatinine is defined the first laboratory values obtained in the emergency department. The maximum difference between the peak creatinine level during the first 72hour of hospitalization and the base line creatinine level was determined for every patients. Cerebral dysfunction is defined using CPC scale. Neurologic exam will be performed on arrival, 24, 48,72 hours after resuscitation and discharge day. Good neurologic outcome is defined as CPC of 1 or 2. The diagnostic accuracy of NGAL in predicting acute kidney injury and neurologic outcome will be evaluated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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