跳至主要内容
临床试验/NCT02300415
NCT02300415撤回不适用

Comparison of Sensitivity Between Presepsine and Arterial Lactate for the Diagnosis of Severe Sepsis and Sepsis Shock in Emergency Department.

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
400
试验地点
1
主要终点
Presepsine and lactate values

研究概览

简要总结

Severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. The potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. Conventional biomarkers are an important support for the emergency physician. However, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggests that they can be more efficient in this area.

In this single-center, prospective, non-interventional study, we propose to compare the sensitivity of presepsine to that of lactate for the diagnosis of severe sepsis and septic shock We emit to main hypothesis that the sensitivity of presepsine is higher than that of lactate for the diagnosis of severe sepsis.

详细描述

Severe sepsis and sepsis shock are common in emergency department, with a high mortality rate. The potential severity of this disease impose a diagnosis as early as possible to start antibiotic therapy and hemodynamic support. The conventional biomarkers are an important support for the emergency physician. However, comparison of sensitivity and specificity for new biomarkers, like presepsine, suggest that they can be more efficient in this indication. Presepsine is a soluble fragment of CD14, its concentration is a reflection of cellular activity (macrophages and monocytes) in response of a sepsis's aggression. Today, it's possible to asses the presepsine value at bedside, with new device (PATHFAST), in just 17 minutes, reinforcing the interest for this biomarker.

We will conduct a single-center, prospective, non-interventional study, between december 2014 and July 2015 in the university emergency department of Nice. The primary outcome is to compare the sensitivity of presepsine to lactate for the diagnosis of severe sepsis and septic shock. The dosage of presepsine will be made in 194 patients over 18 years old , with at least two S.I.R.S criteria, a suspected infection, and the presence of one organ failure.

The secondary outcomes are to asses the link between the presepsine value and the germ responsible of sepsis, the correlation between presepsine value at the admission and the mortality at J-28. And we will try to determine if there is a correlation between the initial presepsine value, and the P.I.R.O score.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> 18 years
  • Presence of at least two SIRS criteria (T °> 38.3 ° or <36 °, tachycardia> 90 / min, tachypnea> 20 / min, recent alteration of consciousness)
  • Suspected Infection
  • Indication of an arterial lactate assay on medical advice
  • Affiliation to social security
  • Informed Consent

排除标准

  • Renal dialysis
  • Scalable neoplasia chemotherapy
  • Patient Palliative Care
  • Private Patient freedom or under legal protection

结局指标

主要结局

Presepsine and lactate values

时间窗: Day 0

Presepsine and lactate values at the admission in ED for the patients with severe sepsis criteria

次要结局

  • Germs responsible of sepsis(Day 0)
  • Sepsis shock(Day 0)
  • PIRO Score(Day 0)
  • Mortality(Day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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