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NCT Number: NCT02766166

Critical Health Assessment and Outcomes Score/Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Rates of critical care transfer

    Time frame: through study completion, an average of 1 year

  2. Non-fatal adverse events

    Time frame: through study completion, an average of 1 year

  3. readmission to unit or hospital

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Deeptankar DeMazumder, MD, PhD

CONTACT

[email protected]

513-558-1035

Deeptankar DeMazumder, MD, PhD

CONTACT

[email protected]

513-558-1035

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Indiana University
  • University of Cincinnati

Registry information

Acronym: CHAOS

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
May 9, 2016
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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