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临床试验/NCT05691621
NCT05691621招募中不适用

A Prospective Observational Study of Galectin-3 in Septic and Non-septic Acute Kidney Injury

Fengyun Wang1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
The levels of Gal3

研究概览

简要总结

Acute kidney injury (AKI) is a common critical condition with high morbidity and mortality. The level of circulating Galectin-3 (Gal3) largely depends on renal function, so it is elevated in patients with AKI or CKD; elevated Gal3 also aggravates the progression of CKD after the onset of AKI. The proinflammatory and profibrotic properties of Gal3 may render it to be one of the key molecules mediating AKI, CKD, and cardiorenal syndrome. In this prospective observational study, the investigators will explore the differences of Gal3 levels among septic AKI, non-septic AKI, and non-AKI patients and its correlation with prognosis, inflammation, and disease severity in the ICU.

详细描述

Acute kidney injury (AKI) is a common critical condition with high morbidity and mortality. Not only can AKI cause death in the acute phase, but also can it be associated with the development of chronic kidney disease (CKD) or the progression of CKD. Galectins are members of a lectin family widely expressed in vertebrates, among which galectin-3 (Gal3) is the most studied one. The level of circulating Gal3 largely depends on renal function, so it is elevated in patients with AKI or CKD; elevated Gal3 also aggravates the progression of CKD after the onset of AKI. The proinflammatory and profibrotic properties of Gal3 may render it to be one of the key molecules mediating AKI, CKD, and cardiorenal syndrome. However, the mechanisms of AKI differ from different etiologies, and the process and extent of levels of Gal3 may be also different, so its predictive value in prognosis may vary in different types of AKI. In critically ill patients, AKI is a common complication of sepsis, and sepsis is the most common trigger of AKI. In this prospective observational study, the investigators will explore the differences of Gal3 levels among septic AKI, non-septic AKI, and non-AKI patients and its correlation with prognosis, inflammation, and disease severity in the ICU.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old or more.
  • The patient himself or his agent is able to provide informed consent and provide adequate information for the endpoint assessment.
  • Renal function was stable before this onset, and there was no evidence of plasma creatinine rising by 0.3 mg/dL within 3 months of study entry and not receiving RRT.

排除标准

  • Age less 18 years old.
  • There were previous acute kidney injury, kidney transplantation, chronic kidney disease, or with a glomerular filtration rate of less than 30 mL/min, or hepatorenal syndrome, or pregnancy.
  • Patients with an expected survival time of less than 6 months.

研究组 & 干预措施

septic AKI: S-AKI

Septic patients with AKI

干预措施: Standard Reagents, Whole Blood (Drug)

non-septic AKI: non-S AKI

Non-septic critically ill patients with AKI.

干预措施: Standard Reagents, Whole Blood (Drug)

non-AKI Non-AKI

Critically ill patients without sepsis and AKI.

干预措施: Standard Reagents, Whole Blood (Drug)

结局指标

主要结局

The levels of Gal3

时间窗: 2023-01~2023-08

The levels of Gal3 in septic AKI, non-septic AKI, and non-AKI patients in the ICU

次要结局

  • Length of stay in the ICU(2023-01~2023-08)
  • Mortality(2023-01~2023-08)
  • IL-6(2023-01~2023-08)
  • Renal replacement therapy incidence(2023-01~2023-08)
  • Cardiovascular events incidence(2023-01~2023-08)
  • TIMP-2(2023-01~2023-08)
  • HMGB1(2023-01~2023-08)
  • NGAL(2023-01~2023-08)

研究者

发起方
Fengyun Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fengyun Wang

Principal Investigator

First People's Hospital of Foshan

研究点 (1)

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