Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-03 @ 11:29 PM
Study NCT ID:
NCT01810133
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Co-morbidity Scales
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230034}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-16', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients that died after surgery during their hospital stay', 'timeFrame': '1 year', 'description': 'Electronic patient charts are revised for the complete hospital length of stay for co-morbidities, intra-operative data and post-operative all-cause in-hospital mortality.'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay associated with surgery', 'timeFrame': '1 year', 'description': 'Electronic patient charts are revised for the complete hospital length of stay for co-morbidities, intra-operative data and post-operative all-cause in-hospital mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Comorbidity'], 'conditions': ['Postoperative Mortality']}, 'descriptionModule': {'briefSummary': "Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status (American Society of Anesthesiology) is the most commonly scale to assess this parameter and has yet been repeatedly criticized in the past for its discriminatory power.\n\nFew studies have shown both the ASA physical status and the more detailed and more time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.\n\nThe purpose of this observational study is to compare the predictive value of both scales with regards to all-cause in-hospital mortality and hospital length of stay."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing general anesthesia between January 2006 and December 2011', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) All male and female Patients who underwent anesthesia within the study time period (January 2006 and December 2011) in the Charité - University Berlin, Department of Anesthesiology and Intensive Care Medicine CVK/CCM.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT01810133', 'acronym': 'Ko-MoSkau', 'briefTitle': 'Evaluation of Co-morbidity Scales', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Retrospective Data Analysis: Evaluation of Co-morbidity Scales in Peri-operative Medicine', 'orgStudyIdInfo': {'id': 'Ko-MoSkaU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anesthesia patients', 'description': 'All patients undergoing general anesthesia between January 2006 and December 2011 in Charité - University Berlin'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'Germany', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine, CVK and CCM, Charité-University', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology and Intensive Care Medicine, CVK/CCM', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}