NCT04872010

Brief Summary

Establish a structured clinical database for sepsis screening, and establish a special data set standard for sepsis throughout the life cycle.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

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

First Submitted

Initial submission to the registry

April 10, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

April 10, 2021

Last Update Submit

May 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sepsis organ function status and survival analysis.

    Safety indicators include: prognosis: mortality, intensive care unit (ICU) treatment time and hospital stay, incidence of nosocomial infections, treatment-related complications.

    2022.09.30

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1-100 years

You may qualify if:

  • Patients with sepsis who meet the Sepsis 3.0 standard proposed by the 2016 International Sepsis Expert Consensus, that is, for patients with infection or suspected infection, when sepsis-related sequential organ failure (Sequential (Sepsis-related) Organ Failure) Assessment (SOFA) score increased by ≥ 2 points from the baseline can be diagnosed as sepsis;
  • It is estimated that the patient's ICU stay ≥24 hours;
  • Obtain informed consent and sign an informed consent form.

You may not qualify if:

  • The patient's ICU hospital stay is less than 24 hours;
  • Participated in other clinical research;
  • Failed to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Dean of Xinhua Hospital, Leader of Emergency Medicine Science Department

Study Record Dates

First Submitted

April 10, 2021

First Posted

May 4, 2021

Study Start

June 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

May 4, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share