Critical Health Assessment and Outcomes Score/Study

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Johns Hopkins University
Study ID
NCT02766166
Status
Recruiting
Apply to this trial

Conditions

  • Critical Illness
  • Death, Sudden

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Sep 1, 2019
Status verified
Sep 2022
Primary completion
Sep 1, 2025
Completion
Sep 1, 2027

Study Design

Enrollment
200,000 participants (estimated)

Arms

  • Arm: Predictive Monitoring
  • Arm: No Predictive Monitoring

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Deeptankar DeMazumder, MD, PhD
[email protected]
Johns Hopkins UniversityBaltimoreMaryland21205
Steven R. Jones, MD
[email protected]
Deeptankar DeMazumder, MD, PhD
[email protected]
University of CincinnatiCincinnatiOhio45267-0542
Benjamin L. Vaughan, PhD
[email protected]
Deeptankar DeMazumder, MD, PhD
[email protected]

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