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Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients

2017年8月28日 更新者：Ulrike Holzinger、Medical University of Vienna

Evaluation of Intestinal Brush Border Enzyme Function in Patients With SIRS and Septic Shock Compared to Control Patients

The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Systemic Inflammatory Response Syndrome (SIRS), sepsis, septic shock and concomitant multiorgan failure are major causes of morbidity and mortality in intensive care units. During SIRS and septic shock the role of the gut seems to be uncertain. As it serves as an intestinal barrier which allows the symbiotic relationship between man and enteric bacteria, increased gut permeability during critical illness is accused to promote sepsis. Brush border enzymes have the ability to detoxify lipopolysaccharides and prevent bacterial invasion across the gut mucosal barrier. A reduced brush border enzyme function could contribute to the gastrointestinal intolerance in critically ill patients, which is frequently observed. The aim of this study is to assess the influence of SIRS and septic shock on brush border enzyme morphology and function in men.

研究类型

介入性

注册 (实际的)

39

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 奥地利
      • Vienna、奥地利、1090
        • Medical University Vienna

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Septic Shock:

Recruitment and inclusion criteria

  • 15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR > 20/min, HR > 90/min, Temp. > 38°/< 36°, 12G/l< WBC < 4G/l; assumed or proven infection, persistent hypotension refractory to fluid therapy and need for vasopressors.
  • Time window for inclusion: up to 72h after onset of symptoms

Exclusion criteria

  • PLT < 50G/l,
  • PT < 50%,
  • Continuous therapeutic anticoagulation,
  • DIC, st. p. MCI within 14 days,
  • Gastrointestinal perforation,
  • Age < 18 years,
  • Age > 80 Years

SIRS:

Recruitment and inclusion criteria

  • 15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR > 20/min, HR > 90/min, Temp. > 38°/< 36°, 12G/l < WBC < 4G/l; assumed or proven infection
  • Time window for inclusion: up to 72h after onset of symptoms

Exclusion criteria:

  • PLT < 50G/l,
  • PT < 50%, continuous therapeutic anticoagulation,
  • DIC, st. p. MCI within 14 days,
  • Gastrointestinal perforation,
  • Age < 18 years,
  • Age > 80 Years

Healthy/controls:

  • 15 control subjects will be recruited from the outpatient ward referred to the endoscopy of the Department of Medicine III - Division of Gastroenterology and Hepatology for upper GI-endoscopy because of epigastric pain or reflux symptoms.

Inclusion criteria:

  • Signed informed consent

Exclusion criteria:

  • Patients with diarrhea of unknown origin, IBD or known celiac disease
  • Age < 18 years
  • Age > 80 Years
  • PLT < 50G/l, PT < 50%
  • Therapeutic oral anticoagulation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Septic Shock
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients with septic shock
程序：Gastroscopy
When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
其他：SIRS
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients with SIRS
程序：Gastroscopy
When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
其他：healthy/controls
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients without SIRS/septic shock
程序：Gastroscopy
When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
activity of the brush border membrane enzyme intestinal alkaline phosphatase
大体时间：at inclusion
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen. Determination of enzyme activity will be done within 28 days.
at inclusion

次要结果测量

结果测量
措施说明
大体时间
activity of the brush border membrane enzyme maltase
大体时间：at inclusion
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen. Determination of enzyme activity will be done within 28 days.
at inclusion
activity of the brush border membrane enzyme lactase
大体时间：at inclusion
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen. Determination of enzyme activity will be done within 28 days.
at inclusion
Brush border morphology
大体时间：at inclusion
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen. Determination of enzyme activity will be done within 28 days.
at inclusion
ICU mortality
大体时间：at ICU discharge
only for groups "septic shock" and "SIRS"
at ICU discharge
hospital mortality
大体时间：at hospital discharge
only for groups "septic shock" and "SIRS"
at hospital discharge
mortality (6 months)
大体时间：6 months after inclusion
6 months after inclusion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medical University of Vienna

调查人员

  • 首席研究员：Ulrike Holzinger, MD、Medical University of Vienna

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年7月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2012年4月12日

首先提交符合 QC 标准的

2012年4月24日

首次发布 (估计)

2012年4月26日

研究记录更新

最后更新发布 (实际的)

2017年8月29日

上次提交的符合 QC 标准的更新

2017年8月28日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BBM_septic_shock

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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