跳至主要内容
临床试验/NCT06001294
NCT06001294招募中不适用

The Value of Serum ELABELA in Early Diagnosis of Sepsis-Associated Acute Kidney Injury

Xiangcheng Zhang1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
The value of ELABELA

研究概览

简要总结

The investigators selected patients diagnosed with sepsis who were admitted to the Intensive Care Unit (ICU) of Huai'an First People's Hospital between June 2022 and December 2023, as well as healthy individuals with normal kidney function during the same period, for the research. The investigators collected blood samples from patients with septic shock or sepsis at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days, and 7 days after diagnosis, and also collected blood samples from the healthy individuals. The blood samples were stored in gel separation vacuum tubes containing heparin as an anticoagulant. The supernatant was removed and stored at -80°C, and the levels of plasma ELA (enzyme-linked immunosorbent assay) were measured using a standardized ELA kit. Additionally, serum NGAL (neutrophil gelatinase-associated lipocalin) and creatinine levels were measured simultaneously. The subjects were divided into three groups based on the KDIGO diagnostic criteria: sepsis-associated acute kidney injury (S-AKI) group, sepsis non-AKI group, and normal control group. Finally, the data were analyzed to determine the early diagnostic value of ELA for S-AKI. Approximately 70 specimens were collected in total.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patients with sepsis admitted to the ICU.

排除标准

  • Under 18 years old;
  • History of chronic kidney disease;
  • Recipients of organ transplantation within the past year;
  • Patients or their families could not give informed consent.

结局指标

主要结局

The value of ELABELA

时间窗: Venous blood samples were collected at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days and 7 days after the diagnosis of sepsis or septic shock

Significance of serum ELABELA in the early diagnosis of sepsis-associated renal injury.

次要结局

  • 7-day survival rate(7-day)

研究者

发起方
Xiangcheng Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiangcheng Zhang

Director of Intensive Care Medicine Department, Huai'an First People's Hospital

Huai'an No.1 People's Hospital

研究点 (1)

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