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Critical Health Assessment and Outcomes Score/Study

Critical Health Assessment and Outcomes Score/Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02766166
Acronym
CHAOS
Enrollment
200000
Registered
2016-05-09
Start date
2019-09-01
Completion date
2027-09-01
Last updated
2022-10-10

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

Conditions

Critical Illness, Death, Sudden

Brief summary

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.

Interventions

None listed

Sponsors

University of Cincinnati
CollaboratorOTHER
Indiana University
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* All patients age 18-100 years admitted to a bed or OR with telemetry monitoring capability will be included.

Exclusion criteria

* Children (individuals \<18 years of age).

Design outcomes

Primary

MeasureTime frame
Time to MortalityFrom 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 stayFrom 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

Secondary

MeasureTime frame
Rates of critical care transferthrough study completion, an average of 1 year
Non-fatal adverse eventsthrough study completion, an average of 1 year
readmission to unit or hospital30 days

Countries

United States

Contacts

Primary ContactDeeptankar DeMazumder, MD, PhD
DDeMazu@iu.edu513-558-1035
Backup ContactDeeptankar DeMazumder, MD, PhD
Deeptankar@gmail.com513-558-1035

Outcome results

None listed

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