跳至主要内容
临床试验/NCT02750163
NCT02750163已完成不适用

Circulating Free Hemoglobin and Microcirculation After Administration of Paracetamol in Febrile Septic Patient

Università Politecnica delle Marche1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年7月5日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Perfused Vessel Density (PVD)

研究概览

简要总结

The aim of this study is to evaluate the effect of Acetaminophen on the main parameters of microcirculation, on the plasmatic levels of free hemoglobin/oxidative stress markers and on the expression of PD1/Pd-L1, in pyrexial septic patient.

详细描述

It has been established that plasma levels of extra-cellular free hemoglobin increased significantly in patients with certain disease, including sickle cellular disease, or undergoing invasive treatments, like coronary bypass surgery, blood transfusions and hemodialysis.

In all these conditions, high levels of free hemoglobin were associated with poor outcome and with serious complications such as acute renal failure and myocardial infarction.

In the animal model of sepsis, increased values of plasma free hemoglobin has been related to increased mortality, especially if a concomitant lack of haptoglobin and hemopexin coexists.

It is likely that the release of free hemoglobin in the blood of septic patient is attributable to changes in the membrane of red blood cells.

These changes have been recognized in humans as a source of damage of the vascular endothelium and consumption of free radical scavenger systems.

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

  • Patients with sepsis, severe sepsis and septic shock with high body temperature that need administration of Paracetamol and which have previously monitored blood pressure and have a central venous catheter in place.

排除标准

  • age < 18 years
  • pregnancy
  • hemodialysis
  • hemolysis of the blood sample
  • use of Paracetamol in the previous 12 hours
  • conditions that do not allow the possibility of getting a monitoring of sublingual microcirculation (maxillofacial trauma, serious inability to jaw, copious blood loss or secretions from the mouth)

结局指标

主要结局

Perfused Vessel Density (PVD)

时间窗: 30 minutes

The perfused vessel density (PVD), unit of measure mm/mm2, is detected in vivo by Incident Dark Field Imaging at sublingual microcirculation. It represents the quantity of well perfused vessels at microcirculatory level.

次要结局

  • StO2 upload(30 minutes)
  • Microcirculatory flow index (MFI)(30 minutes)

研究者

发起方
Università Politecnica delle Marche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abele Donati, MD

Associate Professor

Università Politecnica delle Marche

研究点 (1)

Loading locations...

相似试验