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

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.

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Key information

Conditions

Critical Care Medicine Mortality Prediction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

In-hospital Mortality

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.

Death events occurring during the patient's current hospitalization.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

Peking University

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Aug 31, 2026
Registry last updated: Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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