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Completed

NCT Number: NCT03200158

Study on Correlated Factors of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)

To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).

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Key information

Conditions

Stress Related Mucosal Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

38 patients admitted to ICU and 15 healthy volunteers were successively enrolled in this study.The healthy volunteers were treated with endoscopy and biopsy .The 38 patients were treated with bedside gastroscopy and diagnosed with SRMD due to illness. The acute physiology and chronic health evaluation（APACHE）II score were evaluated, malondialdehyde (MDA) as an index of oxygen radical-lipid peroxidation was assessed in the serum. Transforming growth factor(TGF)β1,claudin3, interleukin (IL) 1 and interleukin（IL）10 levels in the gastric mucosa and plasma level of superoxide dismutase(SOD)，Ischemic modified albumin(IMA)and C-reactive protein（CRP）were evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Occurrence time: ≤72h.
  • With complete clinical data.
  • Patients admitted to ICU were treated with bedside endoscopy and diagnosed with SRMD.

Exclusion criteria

  • Primary digestive tract diseases included stomach cancer, gastric ulcer, cirrhosis with esophagus fundus ventricularis varices and esophageal cancer.
  • Patients were complicated with gastric perforation.
  • Nonsteroidal anti-inflammatory drugs and antiplatelet agents had been used recently, or with the history of major surgery.

Treatment and study plan

Endoscopy biopsy and blood

Other

Medical operation

Primary outcomes

  1. malondialdehyde (MDA)（nmol/mL）

    Time frame: Month 1

    MDA is an index of oxygen radical-lipid peroxidation was assessed in the serum。Thiobarbituric acid （TBA）method was applied for MDA.

  2. superoxide dismutase(SOD)(u/mL)

    Time frame: Month 1

    The activity of superoxide dismutase(SOD) reflects the the antioxidant ，capacity.Pyrogallol substrate method was applied for SOD.

  3. claudin3

    Time frame: Month 1

    Tight junctions (TJs) are the most apical component of the intercellular junctional complexes. TJs consist of occludin, the claudin family of proteins, and junctional adhesion molecule (JAM).Among these TJ molecules, claudins are major integral membrane proteins of TJ strands.Studies have shown that H2O2 can change the number of claudin-3.Previously in vitro experiments have reported that H2O2 increases the permeability of the epithelial monolayer by splitting the cell-tight junction complex structure. In our study,the claudin3 in gastric mucosa was measured by western blot method.

  4. TGFβ1

    Time frame: Month 2

    Measurement of TGFβ1 in gastric mucosa by immunohistochemistry method and microscopic observation.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.We may collect serm to test TGFβ1 using ELISA method，or we may omit this step.

  5. Acute physiology and chronic health evaluation（APACHE）II score

    Time frame: Month 3

    Acute physiology and chronic health evaluation（APACHE）II score was completed within 24h after admitting, including 12 physiological parameters (each item 0-4 points, total score 0-60 points), age (0-6 points) and chronic disease health status (2-5 points). The total score was 0-71 points. The higher the score, the more severe the illness will be.

  6. interleukin（IL）1β

    Time frame: month 4

    Measurement of interleukin（IL）1β in gastric mucosa by immunohistochemistry method.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.We may collect serm to test IL1β using ELISA method，or we may omit this step.

  7. interleukin（IL）10

    Time frame: Month 5

    We measure interleukin（IL）10 in gastric mucosa by immunohistochemistry method.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.We may collect serm to test IL10 using ELISA method，or we may omit this step.

  8. Nitric oxide synthasei（iNOS）

    Time frame: Month 6

    Measurement of inducible nitric oxide synthasei（iNOS ）in gastric mucosa by immunohistochemistry method.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.

Secondary outcomes

  1. Ischemic modified albumin（IMA）(u/ml)

    Time frame: Month 7

    Ischemic modified albumin(IMA) is a candidate marker for assessing myocardial ischemia which has been identified as a marker of oxidative stress in a number of studies.Free cobalt colorimetric method was applied for IMA.

  2. C-reactive protein（CRP）

    Time frame: Month 8

    Latex immunoturbidimetric method was applied for C-reactive protein（CRP）.

Sponsors and collaborators

Lead sponsor

Xiuli Zuo

Other

Collaborators

  • Qilu Hospital of Shandong University

Registry information

Official study title

Study on Changes of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2017
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.