NCT04957888

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

June 29, 2021

Last Update Submit

July 7, 2021

Conditions

Acute Gastrointestinal Injury

Keywords

microbiomemetabolomebiomarker

Outcome Measures

Primary Outcomes (1)

  • The AUC value of the combined markers

    The combined diagnostic accuracy of AGI through omic parameters

    1 year

Study Arms (2)

training group

the observational group to find out the potential biomarker

Other: none intervention

validation group

the validation group to validate the parameters used for early diagnosis

Other: none intervention

Interventions

none interventionOTHER

none intervention.

training groupvalidation group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ICU patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 12, 2021

Study Start

July 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)