CClinicalTrials.gg
RecruitingNCT02766166CHAOSUpdated Oct 10, 2022

Critical Health Assessment and Outcomes Score/Study

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Critical Illness
  • Death, Sudden
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All patients admitted to the hospital, including ward bed or surgical operating room with telemetry monitoring capability.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Children (individuals \<18 years of age).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Predictive Monitoring
  • No Predictive Monitoring
05

What researchers measure

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

06

Study locations

1 of 3 sites recruiting
  • Indiana University
    Indianapolis, Indiana 46202, United States
    Not yet recruiting
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
    Not yet recruiting
  • University of Cincinnati
    Cincinnati, Ohio 45267-0542, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT02766166
Lead sponsor
Johns Hopkins University
Collaborators
University of Cincinnati, Indiana University
Responsible party
Sponsor
First posted
May 9, 2016
Start date
Sep 1, 2019
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Oct 10, 2022

Study contacts

Deeptankar DeMazumder, MD, PhD
Contact
DDeMazu@iu.edu
513-558-1035
Deeptankar DeMazumder, MD, PhD
Contact
Deeptankar@gmail.com
513-558-1035
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion