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临床试验/NCT02920736
NCT02920736Unknown不适用

Value of Urine sTREM-1 on Early Predicting Secondary Acute Kidney Injury in Sepsis: a Mutilcenter and Prospective Clinical Study

Chinese PLA General Hospital0 个研究点目标入组 500 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
主要终点
urine soluble triggering receptor expressed on myeloid cells-1

研究概览

简要总结

The purpose of this study is to determine the value of urine sTREM-1 on early predicting secondary acute kidney injury in sepsis

详细描述

The clinical trial is a prospective, controlled study. All subjects were selected from among inpatients who were hospitalized between Sep.2016 and Dec.2018 in the Respiratory ICU, Surgical ICU and Emergency ICU of 6 general hospitals in Beijing. Based on the Sepsis 3.0,the population(500 subjects) selected met the diagnostic criteria. Based on the KDIGO (Nephrol Dial Transplant. 2012) defines AKI as 3 degrees, the subjects were divided into acute renal injury group (AKI group) and non-acute renal injury group (non-AKI group). Approximately 110 healthy volunteers enrolled as control group. Urine samples were collected from day 1 to day 28 in all patient groups (or to the terminal time point of death), serum samples were collected on days 1, 3, 5, 7, 10, and 14 and the samples were collected from healthy subjects on the day of enrollment. Blood was centrifuged at 3,000 rpm for 15 minutes, and urine at 2,000 rpm for 5 minutes. The supernatants were transferred to Eppendorf tubes and stored at -80°C. All the specimens were re-numbered before the experiment. Urine sTREM-1 was measured by a double antibody sandwich ELISA. This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2014-113-02). The following clinical datas were recorded for all patients through the unified database software: (1) basic clinical information: hospital number, gender, age, underlying disease, hospital admission. (2) Daily vital signs after admission: body temperature, blood pressure, heart rate, respiratory rate, 24h urine volume, Glasgow score. (3) APACHE II score and SOFA score: arterial blood gas analysis, blood routine, C-reactive protein, procalcitonin, blood biochemistry (liver function, renal function, brain natriuretic peptide, blood electrolytes) The APACHE II score and the SOFA score were calculated. (4) 28-day outcome (survival or death). Statistical analyses were conducted by SPSS 16.0 (SPSS, Chicago,IL, USA) and a two-tailed P < 0.05 was considered significant.

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

入选标准

  • All subjects meet the standards of sepsis 3.0 diagnostic criteria for the diagnosis of sepsis.

排除标准

  • The following situations can not occur when all subjects are enrolled
  • Age> 80 years or <18 years
  • Chronic renal insufficiency, renal transplantation
  • Blood purification treatment
  • AKI has occurred

结局指标

主要结局

urine soluble triggering receptor expressed on myeloid cells-1

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lixin Xie

Principal Investigator

Chinese PLA General Hospital

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