跳至主要内容
临床试验/NCT03263325
NCT03263325招募中不适用

Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
AKI

研究概览

简要总结

Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes.

A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury.

This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.

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
— 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • less than or equal to 8 years of age
  • scheduled for cardiac surgery

排除标准

  • severe pre-existing renal insufficiency

研究组 & 干预措施

AKI Group

Patients developing AKI after surgery

干预措施: Discarded urine sample (Other)

No AKI Group

Patients who do not develop AKI after surgery

干预措施: Discarded urine sample (Other)

结局指标

主要结局

AKI

时间窗: within 72 hours after surgery

development of AKI

次要结局

未报告次要终点

研究者

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

Douglas Atkinson

Cardiac Anesthesiologist

Boston Children's Hospital

研究点 (2)

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