CompletedNot Applicable

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

China55,940 participantsStarted 2017-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From ICU admission to 7 days after admission (for outcome prediction)

Calibration of predicted risk, measured by the Brier Score

Timeframe: From ICU admission to 7 days after admission (for outcome assessment).

Sensitivity (Recall) for the composite outcome at a pre-defined risk threshold

Timeframe: From ICU admission to 7 days after admission (for outcome assessment).

Trial details

NCT IDNCT07317817

SponsorChongqing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-31

View on ClinicalTrials.gov More Sepsis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: From ICU admission to 7 days after admission (for outcome prediction)

Calibration of predicted risk, measured by the Brier Score

Timeframe: From ICU admission to 7 days after admission (for outcome assessment).

Sensitivity (Recall) for the composite outcome at a pre-defined risk threshold

Timeframe: From ICU admission to 7 days after admission (for outcome assessment).