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Status unknownNCT05088850Updated Oct 22, 2021

The Early Prediction of Sepsis in ICU

An observational study in Prediction of Sepsis in Critical Patients, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Ruijin Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
14 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Prediction of Sepsis in Critical Patients

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03

In context

Sepsis

1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's planned enrollment of 400 is above the median of 160 across 929 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients that were admitted into the ICU.

Inclusion criteria

Patients who met all of the following criteria were included in the case group:

  1. At least 14 years old.
  2. Sepsis onset at least 5 hours after ICU admission.
  3. Sepsis onset is the first instance since admission to the hospital.

Exclusion criteria

Exclusion Criteria:

Patients meeting all of the following criteria were included in the control group:

  1. At least 14 years old.
  2. Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
  3. Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
  4. SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • non-sepsis

    Other: no intervention

  • sepsis

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

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What researchers measure

Primary outcomes

  1. confidence index of sepsis occurrence

    Time frame: sepsis occurrence in five hours

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Study locations

1 of 1 sites recruiting
  • ICU, Ruijin Hospital
    Shanghai, Shanghai 200025, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05088850
Lead sponsor
Ruijin Hospital
Responsible party
lei li (chief physician, Ruijin Hospital) — Principal investigator
First posted
Oct 22, 2021
Start date
May 30, 2020
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 22, 2021

Study contacts

Ranran Li, PhD
Contact
rebecca1009@hotmail.com
18317059746

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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