Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

Sepsis Clinical Trial

Official title:

Study of Biomarkers in Blood and Tissue Samples of Septic Patients Complicated With Gastrointestinal Dysfunction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04647201
• Other study ID #: SGI-2020-11
• Status: Not yet recruiting
• Start date: November 23, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: Tianjin Nankai Hospital
• Contact: Yingya Cao, MD
• Phone: 15055324662
• Email: caoyingya1990[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Title: Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

2. Research center: Single-center study.

3. Design of the research: A prospective and cohort study.

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. 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.

Description:

This study is a single-center, prospective, cohort study. In this study, the serum samples of septic patients complicated with or without GI are detected. The serum levels of HO-1, PINK1, PLK1as well as oxidative stress and inflammatory markers are compared in different groups. For those who requiring intestinal surgery as treatment, the intestinal tissue specimens are retained. Meanwhile, the clinical symptoms, intestinal motility indicators and intestinal barrier indicators are recorded. In addition, a biomarker model was established to provide important reference for diagnose and management of gastrointestinal dysfunction in septic patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. At least 18 years old

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:

1. Refuse to participate in this study

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

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction
• Sepsis

Locations

Country	Name	City	State
China	Tianjin Nankai Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jianbo Yu

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Reintam Blaser A, Poeze M, Malbrain ML, Björck 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multivariate data analysis of the metabolites	Record the different metabolites between the control group and septic patients	an average of one year
Primary	Multivariate data analysis of the metabolites	Record the different metabolites between the septic patient with or without GI	an average of one year
Secondary	Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with GI	Investigated the metabolites to distinguish the non-survivors from the survivors of sepsis complicated with GI	an average of one year