Critical Health Assessment and Outcomes Score/Study

Critical Illness Clinical Trial

— CHAOS  

Official title:

Critical Health Assessment and Outcomes Score/Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02766166
• Other study ID #: CR02_2017-5045 (central IRB)
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: September 1, 2027

Study information

• Verified date: September 2022
• Source: Johns Hopkins University
• Contact: Deeptankar DeMazumder, MD, PhD
• Phone: 513-558-1035
• Email: DDeMazu[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness
• Death, Sudden

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Cincinnati	Cincinnati	Ohio
United States	Indiana University	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Indiana University, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rates of critical care transfer		through study completion, an average of 1 year
Secondary	Non-fatal adverse events		through study completion, an average of 1 year
Secondary	readmission to unit or hospital		30 days