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临床试验/NCT03494790
NCT03494790已完成不适用

Markers of Inflammation and Metabolism in the ER

University of Helsinki1 个研究点 分布在 1 个国家目标入组 955 人开始时间: 2017年12月15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
955
试验地点
1
主要终点
Days alive without intensive care or high dependency unit treatment

研究概览

简要总结

Adult patients with suspected or confirmed infection and who will be sampled for blood culture will be recruited. Blood samples are collected for the analysis of matrix metalloproteinases (MMP) and their inhibitors. We also aim to analyse metabolic changes and use the samples for analysis of blood lactate, metabolomics, and fibroblast growth factor 21 (FGF-21) as well. The primary aim of the study is to test the performance of MMP-8 in finding severely ill patients who will need treatment in high dependency unit or intensive care. The secondary aim is to study the metabolic changes in acutely ill patients with infection.

详细描述

Adult patients with suspected or confirmed infection and who will be sampled for blood culture (a surrogate for suspected severe infection) will be recruited from three large emergency departments in a University hospital. Two blood samples will be collected: one for the analysis of matrix metalloproteinases, their inhibitor tissue inhibitor of metalloproteinase-1 (TIMP-1), FGF-21 and metabolomic analyses. Another blood sample is for the analysis of blood lactate. Clinical data will be collected to calculate quick SOFA (qSOFA), in order to test whether lactate and/or MMP-8 will improve the prognostic model if they are added to qSOFA. The primary outcome measure is the number of days alive without the need for ICU or high dependency unit treatment. The ability of MMP-8 to discriminate severe infection from uneventful course of the disease will be studied. The secondary aim is to study the metabolic changes in acutely ill patients with infection and compare these variables between survivors and non-survivors. The planned number of patients recruited is 924. During this study the feasibility of a bedside rapid analysis of MMP-8 will be tested in 30 patients and the results obtained using the rapid analyser compared with laboratory results obtained using ELISA.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or more Suspected or confirmed infection Admitted to any of the three emergency departments of university hospital Decision of blood culture

排除标准

  • Age <18 Cancer with metastases Decision of treatment limitation probable or made Consent not obtainable

结局指标

主要结局

Days alive without intensive care or high dependency unit treatment

时间窗: 2 weeks from study admission

Accounts for patients who survive and need no ICU or high dependency care for the primary infection.

次要结局

  • 30 day mortality(30 days)
  • 90 day mortality(90 days)

研究者

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

Johanna Hastbacka

MD,PhD

University of Helsinki

研究点 (1)

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