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临床试验/NCT04767893
NCT04767893已完成不适用

Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients

Sohag University1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2019年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS

研究概览

简要总结

This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.

详细描述

Sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (SIRS) manifestations. Patients with SIRS as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. New biomarkers such as sTREM-1 and sUPAR can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. Also these soluble biomarkers can be used for predicting the prognosis of sepsis patients

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Temperature of >38oC
  • Heart rate of >90 beats/min
  • Respiratory rate of >20 breaths/min
  • Partial pressure of arterial carbon dioxide (PaCO2) of <32 mmHg
  • White blood cell (WBC) count of >12,000 cells/mm3

排除标准

  • HIV patients
  • Patients with neutropenia <1000 cells/mm3
  • <18 years of age.

结局指标

主要结局

Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS

时间窗: in the 7th day after appearance of clinical signs of infection

by ELISA"enzyme linked immunosorbent assay"

Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS

时间窗: in the 7th day after appearance of clinical signs of infection

by ELISA"enzyme linked immunosorbent assay"

Measurement of the serum level of sUPAR (ng/L) in the ICU patients

时间窗: in the 1st day after appearance of clinical signs of infection

by ELISA"enzyme linked immunosorbent assay"

Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS

时间窗: in the 7th day after appearance of clinical signs of infection

by turbidimetry

次要结局

  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score designed to measure the severity of disease for adult patients admitted to intensive care units in the with criteria of SIRS(in the 7th day after appearance of clinical signs of infection)
  • The sequential organ failure assessment score (SOFA score) had been used to determine the extent of organ dysfunction of ICU patients with criteria of SIRS(in the 7th day after appearance of clinical signs of infection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nahed Fathallah Fahmy

lecturer of medical microbiology & immunology departement -faculty of medicine

Sohag University

研究点 (1)

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Diagnostic and Prognostic Biomarkers of Sepsis | 临床试验