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临床试验/NCT06221293
NCT06221293进行中(未招募)不适用

Study of the Relationship Between Intra-abdominal Pressure, Biomarkers of Bacterial Translocation and Intestinal Wall Damage in Multiple Organ Dysfunction Syndrome.

Karaganda Medical University5 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
5
主要终点
Detection of biomarkers of translocation

研究概览

简要总结

Main scientific hypotheses of the project:

  1. The level of intestinal microflora translocation markers and biomarkers of intestinal wall damage the in the blood serum correlates with the level of intra-abdominal pressure, regardless of the genesis of intra-abdominal hypertension.

  2. The critical levels of intestinal microflora translocation markers and biomarkers of the intestinal wall damage can be used for predicting an unfavorable outcome in the multiple organ dysfunction syndrome.

  3. The revealed critical level of intra-abdominal pressure is an additional prognostic sign in assessing the course of the multiple organ dysfunction syndrome.

. Project objectives:

  1. To evaluate the indicators of biomarkers of translocation of the intestinal microflora and biomarkers of the intestinal wall damage in the systemic circulation during the development and course of the syndrome of multiple organ dysfunction. Based on the obtained critical levels of markers of translocation of the intestinal microflora and markers of the intestinal wall damage, it will be possible to predict adverse outcomes in patients with multiple organ dysfunction syndrome.
  2. To identify differences in the level of markers of bacterial translocation of the intestinal microflora and the level of markers of the intestinal wall damage in patients with intra-abdominal hypertension. In patients with multiple organ dysfunction syndrome, the levels of biomarkers of bacterial translocation of the intestinal microflora and biomarkers of intestinal wall damage in the blood serum correlate with intra-abdominal pressure indicators, regardless of the etiology of intra-abdominal hypertension.
  3. Assess the impact of the level of intra-abdominal pressure on the development and course of the syndrome of multiple organ dysfunction. To assess the course of the syndrome of multiple organ dysfunction, an additional prognostic marker is the determination of the critical level of intra-abdominal pressure.
  4. Determine the critical levels of biomarkers of intestinal microflora translocation and biomarkers of intestinal wall damage to predict the outcome of diseases accompanied by the development of multiple organ dysfunction syndrome. The obtained critical levels of biomarkers of translocation of the intestinal microflora and biomarkers of the intestinal wall damage will be significant indicators in the syndrome of multiple organ dysfunction for predicting an unfavorable outcome.

详细描述

The aim of the project is to evaluate the impact of intra-abdominal hypertension, biomarkers of bacterial translocation and biomarkers of intestinal wall damage on the course and outcomes of the disease in patients with multiple organ dysfunction.

Today the intestinal microflora translocation is considered as one of the key mechanism of an enhanced systemic inflammatory response that leads to multiple organ dysfunction. In the intensive care unit, in patients in serious condition changes in various body systems develop, including the immune system reacts with the production of endogenous pro-inflammatory mediators, and due to microcirculation disorders, ischemia and hypoxia of the intestinal wall, aggravated by an increase in intra-abdominal pressure, its permeability increases, its barrier function is impaired. As a result, bacteria and/or their endotoxins penetrate the damaged intestinal barrier and further enhance the immune response, which becomes systemic and ultimately leads to multiple organ dysfunction. When the described processes occur, the assessment of splanchnic blood flow becomes especially relevant.

sCD14-ST (presepsin) and LBP (lipopolysaccharide-binding protein) are being studied as biomarkers of bacterial translocation, and I-FABP (Intestinal fatty-acid binding protein), REG3α (regenerating islet-derived protein-3α) and Zonulin (zonulin) are being studied as biomarkers of intestinal wall injury.

The interaction of the macrophage membrane protein CD14 with peptidoglycans of gram-positive and lipopolysaccharides of the walls of gram-negative bacteria leads to the production of sCD14-ST. Presepsin is a biomarker for the early phase of sepsis and a predictor of outcome in septic patients.

LBP increases the sensitization of receptors of cells of the immune system: macrophages, monocytes, neutrophils to bacterial lipopolysaccharide, which leads to the activation of the immune response by releasing pro-inflammatory mediators. LBP appears to be an effective biomarker for bacterial translocation and the development of septic complications.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • registered multiple organ dysfunction syndrome of various genesis
  • over 18 years of age.

排除标准

  • age under 18
  • pregnancy
  • HIV infection

结局指标

主要结局

Detection of biomarkers of translocation

时间窗: 3-10 days

To evaluate the indicators of biomarkers of translocation of the intestinal microflora and biomarkers of the intestinal wall damage in the systemic circulation during the development and course of the syndrome of multiple organ dysfunction. Based on the obtained critical levels of markers of translocation of the intestinal microflora and markers of the intestinal wall damage, it will be possible to predict adverse outcomes in patients with multiple organ dysfunction syndrome.

次要结局

  • The differences between level of bacterial translocation and level of markers of the intestinal wall damage with intraabdominal hypertension(3-10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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