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临床试验/NCT01602354
NCT01602354Unknown不适用

Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock

Azienda Ospedaliero, Universitaria Pisana1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Level of Endotoxin in blood samples

研究概览

简要总结

The purpose of this observational study is to determine whether endotoxin levels and/or their trends can be considered predictive of morbility or mortality in septic shock caused by gram-negative bacteria, searching also for a possible correlation with Simplified Acute Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells (WBC) and Platelets (PLT).

详细描述

Medical literature states that Endotoxin (a structural molecule of the Gram-negative bacteria extracellular membrane) is able to activate target cells such as macrophages and neutrophils, inducing them to produce and release cytokine, nitric oxide and other mediators that cause a systemic inflammatory response that can evolve until to endothelial damage, shock and multi-organ failure (MOF).

Since 2004 it has been possible to better determine the concentration and the activity of endotoxin in plasma, thanks to a reliable and quick to implement method: the EAA (Endotoxin Activity Assay) test, which is an alternative technique for detecting endotoxin in whole blood based on the detection of enhanced respiratory burst activity in neutrophils following their priming by complexes of endotoxin and a specific anti-endotoxin antibody. The EAA shows excellent performance characteristics in recovering endotoxin from spiked samples and can be performed within 30 min, using less than 100µl whole blood.

Participants of this study (all affected by gram-negative septic shock) will show different values of endotoxin in their blood samples during their stay in Intensive Care Unit (ICU), and the investigators will try to figure out if these values and their trends can be somehow predictive of morbility and/or mortality, despite the small number of septic patients and the heterogeneity of their clinical picture.

So, if endotoxin induces sepsis, can the investigators also state that high values and/or trends of endotoxin can be correlated to severity of disease?

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

  • diagnosis of severe sepsis or septic shock
  • acquisition of informed consent
  • age over 18 years old

排除标准

  • any diagnosis different from severe sepsis or septic shock
  • rejection of informed consent by participant
  • age under 18 years old
  • any clinic condition considered not suitable by researcher

结局指标

主要结局

Level of Endotoxin in blood samples

时间窗: admission date (baseline)

Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC

Change of Endotoxin from baseline

时间窗: 7 dayf after admission

Values of endotoxin are also compared to SOFA, SAPSII, PLT, WBC

次要结局

未报告次要终点

研究者

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

Imma Tatiana Borrelli

Principal Investigator

Azienda Ospedaliero, Universitaria Pisana

研究点 (1)

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