SepsisNCT04647201
Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
An observational study of Sepsis and Gastrointestinal Dysfunction, run by Jianbo Yu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Gastrointestinal Dysfunction
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with sepsis complicated with GI
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jianbo Yu, PhD contact
China1 site
Tianjin Nankai Hospital
Tianjin, 300100
Yingya Cao, MD, 15055324662, caoyingya1990@126.com
Jianbo Yu, PhD
About this study
Official title: Study of Biomarkers in Blood and Tissue Samples of Septic Patients Complicated With Gastrointestinal Dysfunction
- Title: Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
- Research center: Single-center study.
- Design of the research: A prospective and cohort study.
- 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.
- Sample size of the research: Not less than 30 patients in each group.
- 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.
- Aim of the research: The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients.
- Statistical analysis: Analytical study.
- The estimated duration of the study#1-2 years.
Read the 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.
- Conditions
- Sepsis, Gastrointestinal Dysfunction
- Keywords
- sepsis, gastrointestinal dysfunction, biomarkers
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Multivariate data analysis of the metabolites
Record the different metabolites between the control group and septic patients
Measured: an average of one year
Multivariate data analysis of the metabolites
Record the different metabolites between the septic patient with or without GI
Measured: an average of one year
Secondary outcomes (1)
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
Measured: an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start23 Nov 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianbo Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianbo Yu, Tianjin Nankai Hospital
- Investigators
- Jianbo Yu, PhD, Study chair, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647201
- Sponsor's protocol ID
- SGI-2020-11
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 30003491Reintam 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.
PubMed 23370829Blaser 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.
PubMed 31418255Reintam 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.
PubMed 30608280Greis 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.
PubMed 28327177
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Biomarkers in Blood and Tissue Samples of Septic Patients Complicated With Gastrointestinal Dysfunction
- ClinicalTrials.gov ID
- NCT04647201
- Acronym / sponsor ID
- SGI-2020-11
- Conditions
- Sepsis, Gastrointestinal Dysfunction
- Keywords
- sepsis, gastrointestinal dysfunction, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jianbo YuUniversity, hospital or other
- Study start
- 23 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Title: Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction
- Research center: Single-center study.
- Design of the research: A prospective and cohort study.
- 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.
- Sample size of the research: Not less than 30 patients in each group.
- 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.
- Aim of the research: The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients.
- Statistical analysis: Analytical study.
- The estimated duration of the study#1-2 years.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with sepsis complicated with GI
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multivariate data analysis of the metabolites
Time frame: an average of one year
Record the different metabolites between the control group and septic patients
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
1 secondary outcome
Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with GI
Time frame: an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 30003491Assimakopoulos 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.
- Background: PubMed 23370829Reintam 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.
- Background: PubMed 31418255Blaser 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.
- Background: PubMed 30608280Reintam 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.
- Background: PubMed 28327177Greis 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianbo Yu, PhD contact
Jianbo Yu, PhD study chair
Tianjin Nankai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Gastrointestinal Dysfunction, run by Jianbo Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingya Cao, MD (15055324662, caoyingya1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivariate data analysis of the metabolites (time frame: an average of one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647201, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.