NCT07795450 Clinical Validation of a Pre-trained and Fine-tuned Model for Analyzing Time-Series Electronic Health Records in Critical Care
| NCT ID | NCT07795450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Critical Care Medicine |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,800 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,800 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07795450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Care Medicine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07795450 currently recruiting?
Yes, NCT07795450 is actively recruiting participants. Contact the research team at zhaohuiying@pku.edu.cn for enrollment information.
Where is the NCT07795450 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07795450 clinical trial?
NCT07795450 is sponsored by Peking University People's Hospital. The trial plans to enroll 4,800 participants.