Study on Correlated Factors of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)
25 juni 2017 uppdaterad av: Xiuli Zuo
Study on Changes 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
53
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Shandong
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Jinan, Shandong, Kina, 250012
- Qilu Hospital, Shandong University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: Endoscopy biopsy and blood
The healthy volunteers were treated with endoscopy biopsy and blood.The patients were treated with bedside endoscopy biopsy and diagnosed with SRMD due to illness，then collect their blood samples.
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Medical operation
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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malondialdehyde (MDA)（nmol/mL）
Tidsram: Month 1
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MDA is an index of oxygen radical-lipid peroxidation was assessed in the serum。Thiobarbituric acid （TBA）method was applied for MDA.
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Month 1
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superoxide dismutase(SOD)(u/mL)
Tidsram: Month 1
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The activity of superoxide dismutase(SOD) reflects the the antioxidant ，capacity.Pyrogallol substrate method was applied for SOD.
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Month 1
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claudin3
Tidsram: Month 1
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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.
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Month 1
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TGFβ1
Tidsram: Month 2
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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.
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Month 2
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Acute physiology and chronic health evaluation（APACHE）II score
Tidsram: Month 3
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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.
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Month 3
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interleukin（IL）1β
Tidsram: month 4
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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.
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month 4
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interleukin（IL）10
Tidsram: Month 5
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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.
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Month 5
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Nitric oxide synthasei（iNOS）
Tidsram: Month 6
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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.
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Month 6
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Ischemic modified albumin（IMA）(u/ml)
Tidsram: Month 7
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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.
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Month 7
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C-reactive protein（CRP）
Tidsram: Month 8
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Latex immunoturbidimetric method was applied for C-reactive protein（CRP）.
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Month 8
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Xiuli Zuo, PhD, Qilu hospital of Shandong University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2016
Primärt slutförande (Faktisk)
1 april 2017
Avslutad studie (Faktisk)
1 april 2017
Studieregistreringsdatum
Först inskickad
9 maj 2017
Först inskickad som uppfyllde QC-kriterierna
25 juni 2017
Första postat (Faktisk)
27 juni 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 juni 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2015SDU-QILU-G006
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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Kliniska prövningar på Endoscopy biopsy and blood
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