Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02892669
Status:
UNKNOWN
Last Update Posted:
2016-09-08
First Post:
2016-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-02', 'studyFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'ICU stay', 'timeFrame': '6 months'}, {'measure': 'Hospital stay', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the intensive care department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults admitted to ICU\n\nExclusion Criteria:\n\n* rhythm other then sinus\n* presence of cardiac pacemaker'}, 'identificationModule': {'nctId': 'NCT02892669', 'briefTitle': 'Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department', 'orgStudyIdInfo': {'id': 'RRV ICU ADMISSION'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients admitted to the intensive care department', 'interventionNames': ['Other: non interventional study']}], 'interventions': [{'name': 'non interventional study', 'type': 'OTHER', 'description': 'non interventional study', 'armGroupLabels': ['patients admitted to the intensive care department']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amit Lehavi, MD', 'role': 'CONTACT', 'email': 'amit.lehavi@gmail.com', 'phone': '972-50-20161419'}, {'name': 'Yaron Bar-Lavie, MD', 'role': 'CONTACT', 'email': 'y_barlavie@rambam.health.gov.il', 'phone': '972-50-2062027'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Pediatric Anesthesia', 'investigatorFullName': 'Dr. Amit Lehavi MD FANZCA', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}