Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT02766166

Conditions

Critical Illness

Death, Sudden

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Critical Illness

Death, Sudden

Study ID

NCT02766166

Start date

Sep 1, 2019

Status verified date

Sep, 2022

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

200000 participants

Anticipated

Interventions and Outcome Measures

Arms

Predictive Monitoring

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Deeptankar DeMazumder, MD, PhD

513-558-1035DDeMazu@iu.edu

Deeptankar DeMazumder, MD, PhD

513-558-1035Deeptankar@gmail.com

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267-0542

Contacts

Benjamin L. Vaughan, PhD

vaughabn@ucmail.uc.edu

Deeptankar DeMazumder, MD, PhD

DDeMazu@iu.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 10, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2022-10-10.