NCT05088850

Brief Summary

Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.

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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration 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

May 30, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

2.6 years

First QC Date

October 18, 2021

Last Update Submit

October 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • confidence index of sepsis occurrence

    sepsis occurrence in five hours

Study Arms (2)

non-sepsis

Other: no intervention

sepsis

Other: no intervention

Interventions

no intervention

non-sepsissepsis

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients that were admitted into the ICU.

You may qualify if:

  • Patients who met all of the following criteria were included in the case group:
  • At least 14 years old.
  • Sepsis onset at least 5 hours after ICU admission.
  • Sepsis onset is the first instance since admission to the hospital.

You may not qualify if:

  • Patients meeting all of the following criteria were included in the control group:
  • At least 14 years old.
  • Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
  • Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
  • SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • Chen Q, Li R, Lin C, Lai C, Chen D, Qu H, Huang Y, Lu W, Tang Y, Li L. Transferability and interpretability of the sepsis prediction models in the intensive care unit. BMC Med Inform Decis Mak. 2022 Dec 29;22(1):343. doi: 10.1186/s12911-022-02090-3.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 22, 2021

Study Start

May 30, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

October 22, 2021

Record last verified: 2021-10

Locations