Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

NCT04647201 | Unknown

• 1 other identifier: SGI-2020-11
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Title: Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
2. 2.Research center: Single-center study.
3. 3.Design of the research: A prospective and cohort study.
4. 4.Object of the research: Patients with age≥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. 5.Sample size of the research: Not less than 30 patients in each group.
6. 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. 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. 8.Statistical analysis: Analytical study.
9. 9.The estimated duration of the study#1-2 years.

Conditions

Sepsis; Gastrointestinal Dysfunction

Keywords

sepsis; gastrointestinal dysfunction; biomarkers

Outcome Measures

Primary Outcomes (2)

• Multivariate data analysis of the metabolites

  Record the different metabolites between the control group and septic patients

  an average of one year

• Multivariate data analysis of the metabolites

  Record the different metabolites between the septic patient with or without GI

  an average of one year

Secondary Outcomes (1)

• Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with GI

  an average of one year

Study Arms (3)

Control

Non-sepsis and non-GI adults

Sepsis patients without GI

Patients who meet the criteria of sepsis3.0 with AGI grade I or less

Sepsis patients with GI

Patients who meet the criteria of sepsis3.0 with AGI grade II or above

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with sepsis complicated with GI

You may qualify if:

• At least 18 years old
• Patients with sepsis who meet the criteria for sepsis 3.0
• Patients complicated gastrointestinal dysfunction with AGI grade II or above
• Agree to participate in this study and sign informed consent

You may not qualify if:

• Refuse to participate in this study
• Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
• Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
• Those who are participating in other drug clinical trials
• Patient with HIV infection, patients in pregnancy or breast stage
• In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study

Sponsors & Collaborators

• Jianbo Yu: lead

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, 300100, China

Location

Related Publications (5)

• 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.

  PMID: 30003491 BACKGROUND

• 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.

  PMID: 23370829 BACKGROUND

• 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.

  PMID: 31418255 BACKGROUND

• 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.

  PMID: 30608280 BACKGROUND

• 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.

  PMID: 28327177 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianbo Yu, PhD

  Tianjin Nankai Hospital

  STUDY CHAIR

Central Study Contacts

Yingya Cao, MD

CONTACT

15055324662; caoyingya1990@126.com

Jianbo Yu, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 30, 2020
• Study Start: November 23, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)