Clinical Validation of a Pre-trained and Fine-tuned Model for Analyzing Time-Series Electronic Health Records in Critical Care

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07795450

Enrollment

4800

Registered

2026-08-31

Start date

2026-01-01

Completion date

2027-12-31

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care Medicine, Mortality Prediction

Keywords

Intensive Care Units, Electronic Health Records, Validation Study, Models, Theoretical, Hospital Mortality

Brief summary

The goal of this observational study is to validate the generalization capability and predictive performance of the "Time-Series Electronic Health Record Foundation Model (EHR Foundation Model)", which was pre-trained on a large-scale critical care dataset, within the real-world clinical environment of the Intensive Care Unit (ICU) at Peking University People's Hospital. The main question it aims to answer is: · Based on the "pre-training + fine-tuning" paradigm, whether the EHR foundation model can effectively provide accurate and dynamic prognostic support information in real-world clinical scenarios. Participants who agree to take part in the research, in addition to completing the signed informed consent form, if the patient's hospital stay is too short, will be obtained information on prognostic outcomes (e.g., 28-day mortality) through telephone follow-up.

Detailed description

The clinical validation design combines a retrospective cohort study with a prospective cohort study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years, no gender restriction; * ICU length of stay ≥ 24 hours (to ensure sufficient time-series monitoring data for model generation); * Complete electronic health record data, including baseline demographic characteristics and at least one complete laboratory test record after ICU admission.

Exclusion criteria

* Patients who are transferred out or die within 24 hours of ICU admission; * Duplicate admission records for non-initial ICU admissions (only the initial ICU admission record is retained to ensure independence); * Severe deficiency in core data (e.g., absence of major vital sign recordings or \> 50% missing key laboratory test results); * Patients with abandonment of treatment or discharge against medical advice, leading to inability to ascertain the definitive clinical outcome.

Design outcomes

Primary

Measure	Time frame	Description
In-hospital Mortality	The endpoints are patient discharge or death. For prognostic outcomes (e.g., 28-day mortality), if the patient's hospital stay is insufficient, the outcome will be obtained through telephone follow-up.	Death events occurring during the patient's current hospitalization.

Countries

China

Contacts

CONTACTHuiying Zhao, PhD

zhaohuiying@pku.edu.cn+86 13811088270

CONTACTXiaojiang Liu, M.Med

liuxiaojiang@pku.org.cn+86 13717952776

Outcome results