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Research on Risk Assessment and Early Warning Models for Adverse Clinical Outcomes in Critically Ill Patients

Research on Risk Assessment and Early Warning Models for Adverse Clinical Outcomes in Critically Ill Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07317817
Enrollment
55940
Registered
2026-01-05
Start date
2017-10-01
Completion date
2024-01-31
Last updated
2026-01-05

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

Conditions

AKI - Acute Kidney Injury, ARDS (Acute Respiratory Distress Syndrome), Sepsis

Brief summary

This is a medical research study that uses information from past patient hospital records. It focuses on three serious conditions that often affect critically ill patients: sepsis (a life-threatening body-wide infection), ARDS (a severe lung injury that makes breathing very difficult), and acute kidney injury (sudden loss of kidney function). The goal is to better understand which patients in the ICU are at highest risk of developing these conditions or getting worse. Researchers will look at de-identified information from medical records of patients treated in the ICU . The study will use computer analysis to find patterns in the data that may help doctors predict these risks earlier. No new treatments are being tested, and no patients will be contacted or recruited for this study. All data used is anonymous to protect patient privacy.

Interventions

OTHERNo intervention (Observational study)

This is a non-interventional, observational study. The aim is to develop and validate a predictive model using existing clinical data. No medical interventions (such as drugs, devices, or procedures) are being administered, assigned, or compared as part of this research protocol. The intervention of interest is the application of the predictive model for risk assessment, which is an analytical procedure, not a patient-directed intervention.

Sponsors

Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (age ≥ 18 years). * Admitted to the ICU with a length of stay ≥ 24 hours. * Availability of key clinical variables within the first 24 hours of ICU admission (e.g., vital signs, laboratory results, admission diagnosis).

Exclusion criteria

* Patients with incomplete or missing key data for model variables (e.g., missing baseline creatinine, or missing Sequential Organ Failure Assessment (SOFA) score components). * Patients admitted for palliative care or comfort measures only upon ICU admission. * Readmissions during the same hospitalization (only the first ICU admission will be included).

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Receiver Operating Characteristic Curve (AUROC) for predicting the composite outcome of Sepsis, ARDS, or Acute Kidney InjuryFrom ICU admission to 7 days after admission (for outcome prediction)The discriminatory power of the machine learning model will be assessed by the AUROC. The value ranges from 0 to 1, with a higher value indicating better ability to distinguish between patients who will and will not experience the composite outcome.
Calibration of predicted risk, measured by the Brier ScoreFrom ICU admission to 7 days after admission (for outcome assessment).The accuracy of the model's predicted probabilities will be assessed using the Brier Score (range 0 to 1, lower scores indicate better calibration). A calibration plot will be presented to visualize the agreement between predicted and observed event rates.
Sensitivity (Recall) for the composite outcome at a pre-defined risk thresholdFrom ICU admission to 7 days after admission (for outcome assessment).Performance metric calculated after applying a pre-defined probability cut-off to classify patients as high-risk or low-risk.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026