Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT02766166
Status:
RECRUITING
Last Update Posted:
2022-10-10
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Critical Health Assessment and Outcomes Score/Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003645', 'term': 'Death, Sudden'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Mortality', 'timeFrame': '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'}, {'measure': 'Duration of ICU/hospital stay', 'timeFrame': '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'}], 'secondaryOutcomes': [{'measure': 'Rates of critical care transfer', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Non-fatal adverse events', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'readmission to unit or hospital', 'timeFrame': '30 days'}]}, 'conditionsModule': {'conditions': ['Critical Illness', 'Death, Sudden']}, 'descriptionModule': {'briefSummary': "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.\n\nBy 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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the hospital, including ward bed or surgical operating room with telemetry monitoring capability.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients age 18-100 years admitted to a bed or OR with telemetry monitoring capability will be included.\n\nExclusion Criteria:\n\n* Children (individuals \\<18 years of age).'}, 'identificationModule': {'nctId': 'NCT02766166', 'acronym': 'CHAOS', 'briefTitle': 'Critical Health Assessment and Outcomes Score/Study', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Critical Health Assessment and Outcomes Score/Study', 'orgStudyIdInfo': {'id': 'CR02_2017-5045 (central IRB)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Predictive Monitoring'}, {'label': 'No Predictive Monitoring'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deeptankar DeMazumder, MD, PhD', 'role': 'CONTACT', 'email': 'DDeMazu@iu.edu'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven R. Jones, MD', 'role': 'CONTACT', 'email': 'sjones64@jhmi.edu'}, {'name': 'Deeptankar DeMazumder, MD, PhD', 'role': 'CONTACT', 'email': 'DDeMazu@iu.edu'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '45267-0542', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin L. Vaughan, PhD', 'role': 'CONTACT', 'email': 'vaughabn@ucmail.uc.edu'}, {'name': 'Deeptankar DeMazumder, MD, PhD', 'role': 'CONTACT', 'email': 'DDeMazu@iu.edu'}], 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Deeptankar DeMazumder, MD, PhD', 'role': 'CONTACT', 'email': 'DDeMazu@iu.edu', 'phone': '513-558-1035'}, {'name': 'Deeptankar DeMazumder, MD, PhD', 'role': 'CONTACT', 'email': 'Deeptankar@gmail.com', 'phone': '513-558-1035'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}, {'name': 'Indiana University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}