Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
NCT ID: NCT04647201
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2020-11-23
2022-06-30
Brief Summary
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2. Research center: Single-center study.
3. Design of the research: A prospective and cohort study.
4. Object of the research: Patients with ageā„18 years those who meet the diagnostic criteria of sepsis 3.0 complicated with GI and grouped into GI group and non-GI adults as control.
5. Sample size of the research: Not less than 30 patients in each group.
6. Research approach: After admission to ICU, patients were assigned to the indicated groups according to the criteria. In addition, blood samples were collected within 24 hours for detecting serum levels of HO-1, PINK1, PLK1as well as oxidative stress and inflammatory markers.For those who requiring intestinal surgery as treatment, the intestinal tissue specimens are retained.
7. Aim of the research: The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients.
8. Statistical analysis: Analytical study.
9. The estimated duration of the study#1-2 years.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Control
Non-sepsis and non-GI adults
No interventions assigned to this group
Sepsis patients without GI
Patients who meet the criteria of sepsis3.0 with AGI grade I or less
No interventions assigned to this group
Sepsis patients with GI
Patients who meet the criteria of sepsis3.0 with AGI grade II or above
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients with sepsis who meet the criteria for sepsis 3.0
3. Patients complicated gastrointestinal dysfunction with AGI grade II or above
4. Agree to participate in this study and sign informed consent
Exclusion Criteria
2. Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
3. Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
4. Those who are participating in other drug clinical trials
5. Patient with HIV infection, patients in pregnancy or breast stage
6. In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study
18 Years
90 Years
ALL
No
Sponsors
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Jianbo Yu
OTHER
Responsible Party
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Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Principal Investigators
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Jianbo Yu, PhD
Role: STUDY_CHAIR
Tianjin Nankai Hospital
Locations
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Tianjin Nankai Hospital
Tianjin, , China
Countries
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Central Contacts
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Jianbo Yu, PhD
Role: CONTACT
Facility Contacts
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Yingya Cao, MD
Role: primary
Jianbo Yu, PhD
Role: backup
References
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Assimakopoulos SF, Triantos C, Thomopoulos K, Fligou F, Maroulis I, Marangos M, Gogos CA. Gut-origin sepsis in the critically ill patient: pathophysiology and treatment. Infection. 2018 Dec;46(6):751-760. doi: 10.1007/s15010-018-1178-5. Epub 2018 Jul 12.
Reintam Blaser A, Poeze M, Malbrain ML, Bjorck M, Oudemans-van Straaten HM, Starkopf J; Gastro-Intestinal Failure Trial Group. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Med. 2013 May;39(5):899-909. doi: 10.1007/s00134-013-2831-1. Epub 2013 Jan 31.
Blaser A, Padar M, Tang J, Dutton J, Forbes A. Citrulline and intestinal fatty acid-binding protein as biomarkers for gastrointestinal dysfunction in the critically ill. Anaesthesiol Intensive Ther. 2019;51(3):230-239. doi: 10.5114/ait.2019.86049.
Reintam Blaser A, Regli A, De Keulenaer B, Kimball EJ, Starkopf L, Davis WA, Greiffenstein P, Starkopf J; Incidence, Risk Factors, and Outcomes of Intra-Abdominal (IROI) Study Investigators. Incidence, Risk Factors, and Outcomes of Intra-Abdominal Hypertension in Critically Ill Patients-A Prospective Multicenter Study (IROI Study). Crit Care Med. 2019 Apr;47(4):535-542. doi: 10.1097/CCM.0000000000003623.
Greis C, Rasuly Z, Janosi RA, Kordelas L, Beelen DW, Liebregts T. Intestinal T lymphocyte homing is associated with gastric emptying and epithelial barrier function in critically ill: a prospective observational study. Crit Care. 2017 Mar 22;21(1):70. doi: 10.1186/s13054-017-1654-9.
Other Identifiers
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SGI-2020-11
Identifier Type: -
Identifier Source: org_study_id