External Validation of the FedHist Dynamic Early Warning Model for Mortality Risk in Critically Ill Patients: A Prospective Multicenter Study

NCT07825012 | Not Yet Recruiting DMC

• 1 other identifier: 2026ZDSYLL335-P01
• Study Type: observational
• Target: 23,579
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess how accurately FedHist, an artificial intelligence model, predicts the risk of death in critically ill patients. Patients in intensive care units (ICUs) can become worse quickly. Updating risk estimates as new clinical information becomes available may help identify patients at higher risk. FedHist uses routinely collected clinical information to estimate a patient's risk of dying in the ICU within the next 24 hours. These estimates are updated every 6 hours. This study will evaluate FedHist prospectively across several hospitals. The model will be integrated into hospital clinical information systems, and its predictions will be compared with observed patient outcomes. The study aims to determine whether FedHist provides accurate predictions across hospitals with different patient populations and clinical practices.

Conditions

ICU

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  The proportion of patients who die from any cause during the ICU stay, with follow-up capped at 90 days after ICU admission. For patients whose ICU stay exceeds 90 days, vital status at day 90 will be used to determine the mortality outcome.

  From ICU admission to ICU discharge or 90 days after ICU admission, whichever occurs first.

Interventions

Risk of mortality OTHER

Patients admitted to the ICU with different risk of mortality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the participating ICU

You may qualify if:

• Admission to a participating ICU

You may not qualify if:

• Age younger than 18 years.
• Expected ICU length of stay shorter than 24 hours.
• Refusal to provide written informed consent.

Sponsors & Collaborators

• Southeast University, China: lead

Central Study Contacts

hui chen

CONTACT

+86-18006138640; huichen.icu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09