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临床试验/NCT06197828
NCT06197828进行中(未招募)不适用

Development and Application of Novel Biomarkers and Clinical Indicators for Early Renal Injury in Children With Sepsis

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Gut microbiota

研究概览

简要总结

Toxicosis often leads to multiple organ failure (MODS), with the kidney being the primary target organ due to its sensitivity to infection and ischemia. The kidney's vulnerability makes it a potential early indicator of organ failure, implying that further organ failure may occur later, thereby increasing the risk of patient mortality. Several studies conducted on sepsis patients in the Pediatric Intensive Care Unit (PICU) have revealed that 40.32% of sepsis patients experienced complications with acute kidney injury (AKI), and the case fatality rate could rise to 70% once AKI occurred. The Kidney Disease Improving Global Outcomes (KDIGO) scale is commonly used as a diagnostic criterion for AKI. However, the kidney's robust reserve function poses a challenge for early identification, diagnosis, and intervention of AKI since significant increases in creatinine levels and a sharp decrease in urine volume already indicate severe kidney damage. This situation calls for the development of alternative methods.

In our previous study, we discovered a strong correlation between urinary oxygen partial pressure and renal organ function impairment in children with sepsis. Building upon traditional biochemical indicators such as blood lactic acid levels, we will incorporate non-invasive tests like urine partial pressure of oxygen, renal ultrasound, and cardiac ultrasound, as well as novel markers like KIM-1, to establish a model for early recognition and assessment of kidney damage in children with sepsis. By utilizing commonly used biomarkers and the precise effects of urinary oxygen partial pressure, we aim to improve early identification and accurate intervention evaluation for pediatric sepsis kidney injury. This research will provide a crucial foundation for the development of early warning systems, diagnostic guidelines, and treatment protocols for pediatric sepsis kidney injury.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • From May 2021 to December 2024, the study focused on patients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days. Specifically, patients with severe infection and those who underwent pediatric neurosurgery were diagnosed with sepsis according to the international standard for childhood sepsis established in 2005, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study spanned from 1 month to 16 years old.

排除标准

  • Children who enter PICU 24 hours and die or exit PICU within 24 hours; Genetic metabolic diseases; Congenital immune deficiency; Can't sign an informed consent form.

结局指标

主要结局

Gut microbiota

时间窗: the first three day after admission

Alterations and specific biomarkers of the intestinal microbiota in patients with sepsis complicated by acute kidney injury

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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