An observational study in Critical Illness and Death, Sudden, sponsored by Johns Hopkins University. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by Johns Hopkins University · Observational
CHAOS is based on the investigator's new and exciting results from pre-clinical and large longitudinal multi-center observational clinical studies of critically ill patients and asymptomatic community-based adults with little or no advanced disease.
By integrating approaches from the physical, biological, computational, statistical and clinical sciences, this observational study will test the hypothesis that early diagnosis of subclinical signatures of critical illness encoded within physiological signals complements conventional clinical predictors by providing unique prognostic insight.
The primary goal is to reduce mortality, morbidity and complications by early identification of individuals with brewing subclinical critical illness and adverse events before overt clinical presentation (e.g., cardiac arrest, arrhythmias, hemorrhage, respiratory failure, circulatory collapse). This will provide the necessary lead time for healthcare providers to deliver early, more effective and/or preventive therapies. Through innovative approaches, CHAOS also meets the challenge of medical errors to reduce missed diagnosis, misdiagnosis, preventable harm and variability in provider adherence to best practice guidelines.
The goal is to validate predictive algorithms and identify subclinical signatures of illness, ranging from asymptomatic adults in the community to very sick patients in the hospital. The overall goal is to make healthcare more precise, effective, efficient, safe and timely while reducing costs, preventable harms and adverse events.
66 studies on the registry are indexed under Death, Sudden; 5 are open to participants now.
This study's planned enrollment of 200,000 is above the median of 262 across 36 observational studies indexed under Death, Sudden.
Browse Death, Sudden studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Compared within Death, Sudden, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All patients admitted to the hospital, including ward bed or surgical operating room with telemetry monitoring capability.
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Exclusion Criteria:
Time to Mortality
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Duration of ICU/hospital stay
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Rates of critical care transfer
Time frame: through study completion, an average of 1 year
Non-fatal adverse events
Time frame: through study completion, an average of 1 year
readmission to unit or hospital
Time frame: 30 days
Started Sep 2019 (actual). Primary completion is estimated for Sep 2025, 72 months after the start.
How these figures are worked out, and which studies are left out of them.
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