Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

November 22, 2020 updated by: Jianbo Yu

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

  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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300100
        • Tianjin Nankai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with sepsis complicated with GI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multivariate data analysis of the metabolites
Time Frame: an average of one year
Record the different metabolites between the control group and septic patients
an average of one year
Multivariate data analysis of the metabolites
Time Frame: an average of one year
Record the different metabolites between the septic patient with or without GI
an average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with GI
Time Frame: an average of one year
Investigated the metabolites to distinguish the non-survivors from the survivors of sepsis complicated with GI
an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianbo Yu

Investigators

  • Study Chair: Jianbo Yu, PhD, Tianjin Nankai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 23, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

November 22, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGI-2020-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All of the individual participant data collected during the trial,after de-identification will be shared.And anyone who wishes to acess the date will beavailable for any purpose

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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