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

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.

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Key information

Conditions

Sepsis AKI - Acute Kidney Injury ARDS (Acute Respiratory Distress Syndrome) Acute Kidney Injury Acute Lung Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Lung Diseases Lung Injury Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Respiratory Tract Diseases Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

No intervention (observational study)

Other

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.

Primary outcomes

Area Under the Receiver Operating Characteristic Curve (AUROC) for predicting the composite outcome of Sepsis, ARDS, or Acute Kidney Injury

Time frame: From 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 Score

Time frame: From 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 threshold

Time frame: From 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.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2024
Study completion: 2024
First posted: Jan 5, 2026
Registry last updated: Jan 5, 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.

Published trials that share one or more normalized conditions with this study.

Completed