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临床试验/NCT02410642
NCT02410642已完成不适用

Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Urinary NAG secretion

研究概览

简要总结

NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.

详细描述

The standard biomarker of AKI, serum creatinine, has poor specificity and sensitivity in the early phases of renal injury. Since the therapeutic window is likely to be in the earlier stages before renal injury is manifest, there is a need for novel diagnostic methods. In the recent years, several new biomarkers of kidney injury have been introduced. To date, none has proven outstanding regarding precision in early detection of AKI. NAG (N-acetyl-b-D-glucosaminidase) is a lysosomal enzyme with high molecular weight. Due to its size, NAG does not normally pass the glomerulus apparatus, but urine levels are elevated after tubulus damage. NAG excretion in urine is seen in AKI after cardiac surgery, exposure to nephrotoxic agents and after renal transplantation. However, its role in clinical decision-making is yet to be established.

We aim to study the excretion pattern of urinary NAG during and after cardiac surgery with cardiopulmonary bypass. Association with perioperative variables will be explored.

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

入选标准

  • •Expected cardiopulmonary bypass time exceeding 60 minutes
  • •Elective surgery

排除标准

  • •End-stage kidney disease with dialysis
  • •Ongoing treatment with nephrotoxic antibiotic agent

结局指标

主要结局

Urinary NAG secretion

时间窗: 24 hours

Secretion pattern of NAG

次要结局

  • Development of AKI (acute kidney injury) according to AKIN criteria(72 hours)

研究者

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

Lukas Lannemyr

MD

Sahlgrenska University Hospital, Sweden

研究点 (1)

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