Acute Gastrointestinal InjuryNCT04957888
Microbial Markers for AGI
An observational study of Acute Gastrointestinal Injury, run by Peking University Third Hospital at 1 site in China.
Trial summary
AGI is very common in ICU and sometimes will trigger the development of gut derived sepsis. Thus, to find out the biomarker in early stage is very important to improve the overall prognosis of critically ill patients. In this project we try to find out the microbial biomarker of AGI through multi-omic technology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Gastrointestinal Injury
- What is being tested?
- none intervention
- How many people
- 584 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jul 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: ICU patients
Inclusion Criteria: All those critically ill patients with anticipated ICU stay for more than 2 days Exclusion Criteria:Patients will be excluded if they have any of the following situations: patients who have not signed the informed consent; Unable to tolerate intra-abdominal pressure monitoring; pregnant woman; Patients after bladder surgery; Systemic diseases and recent use of related drugs; He had a history of infectious diseases, such as tuberculosis or PPD positive. History of hypertension and poor blood pressure control (SBP / DBP > = 140mmHg); Patients with severe mental illness; Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc. were not included if the drug was not stopped within one month before admission.
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Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Investigation on the Microbial Biomarkers of AGI in the Early Stage
AGI is very common in ICU and sometimes will trigger the development of gut derived sepsis. Thus, to find out the biomarker in early stage is very important to improve the overall prognosis of critically ill patients. In this project we try to find out the microbial biomarker of AGI through multi-omic technology.
- Conditions
- Acute Gastrointestinal Injury
- Being tested
- none intervention
- Keywords
- microbiome, metabolome, biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none interventionOther
none intervention.
| Study group | Role | What they receive |
|---|---|---|
| training group | the observational group to find out the potential biomarker Receives: Other: none intervention | |
| validation group | the validation group to validate the parameters used for early diagnosis Receives: Other: none intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The AUC value of the combined markers
The combined diagnostic accuracy of AGI through omic parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jul 2020
- Primary completion1 Jun 2021
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastrointestinal InjuryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957888
- Sponsor's protocol ID
- LM2020203
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Microbial Biomarkers of AGI in the Early Stage
- ClinicalTrials.gov ID
- NCT04957888
- Acronym / sponsor ID
- LM2020203
- Conditions
- Acute Gastrointestinal Injury
- Keywords
- microbiome, metabolome, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 12 Jul 2021 (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.
AGI is very common in ICU and sometimes will trigger the development of gut derived sepsis. Thus, to find out the biomarker in early stage is very important to improve the overall prognosis of critically ill patients. In this project we try to find out the microbial biomarker of AGI through multi-omic technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | – | Other: none interventionthe observational group to find out the potential biomarker |
| validation group | – | Other: none interventionthe validation group to validate the parameters used for early diagnosis |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none interventionnone intervention. | Other | training group, validation group |
Primary outcome
The AUC value of the combined markers
Time frame: 1 year
The combined diagnostic accuracy of AGI through omic parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Gastrointestinal Injury, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AUC value of the combined markers (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2021.