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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Study Setting: Department of Critical Care Medicine (ICU), Peking University People's Hospital. Data Source and Time Period: Retrospective Validation Cohort: Electronic health record data from all patients admitted to the ICU of Peking University People's Hospital between January 1, 2009 and December 31, 2025. This dataset will be used for local fine-tuning and internal validation of the model. Prospective Validation Cohort: Newly diagnosed cases admitted to the ICU of Peking University People's Hospital from March 1, 2026 to December 31, 2026 (following project initiation). This dataset will be used for external independent validation of the model.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

4,800 Participants
are grouped into 2 trial groups
Group A: Non-survivor group
Group B: Survivor group

Trial outcomes

Primary outcomes

1

In-hospital Mortality

Death events occurring during the patient's current hospitalization.

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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