Critical Health Assessment and Outcomes Score/Study

Recruiting

• Conditions: Critical Illness; Death, Sudden

• Registration Number: NCT02766166
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-09
• Study Start: 2019-09-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10
• Primary Completion: 2025-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Mortality	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	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 Outcome Measures

Name	Time	Method
Non-fatal adverse events	through study completion, an average of 1 year
readmission to unit or hospital	30 days
Rates of critical care transfer	through study completion, an average of 1 year

Trial Locations

Locations (3)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States