Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-03 @ 2:27 PM
Study NCT ID:
NCT04281706
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2020-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Etomidate vs. Propofol on Infectious Complications Post Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1495}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sepsis', 'timeFrame': 'surgical intervention to hospital discharge, average 30 days', 'description': 'Incidence of sepsis according to diagnosis-related group coding between surgical intervention and hospital discharge (according to SEPSIS II)'}], 'secondaryOutcomes': [{'measure': 'Pneumonia', 'timeFrame': 'surgical intervention to hospital discharge, average 30 days', 'description': 'Incidence of pneumonia within between surgical intervention and hospital discharge'}, {'measure': 'Mediastinitis', 'timeFrame': 'surgical intervention to hospital discharge, average 30 days', 'description': 'Incidence of mediastinitis within between surgical intervention and hospital discharge'}, {'measure': 'Surgical Site Infections', 'timeFrame': 'surgical intervention to hospital discharge, average 30 days', 'description': 'Incidence of surgical site infections between surgical intervention and hospital discharge'}, {'measure': 'ICU Mortality', 'timeFrame': 'surgical intervention to ICU discharge, average 30 days', 'description': 'Proportion of patients that died before ICU discharge'}, {'measure': 'Hospital mortality', 'timeFrame': 'surgical intervention to hospital discharge, average 30 days', 'description': 'Proportion of patients that died before hospital discharge'}, {'measure': 'Intensive Care Unit length of stay', 'timeFrame': 'ICU admission to ICU discharge, average 30 days', 'description': 'Time patients spend on the ICU'}, {'measure': 'Hospital length of stay', 'timeFrame': 'hospital admission to hospital discharge, average 30 days', 'description': 'Time patients spend admitted to the hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective before-after-study is to evaluate the potential association of etomidate vs. propofol as an induction agent for major cardiac surgery on infectious post-operative complications.\n\nThe investigators hypothesize that etomidate increases the rate post-operative infectious complications in cardiosurgical patients.', 'detailedDescription': 'Etomidate had been a standard induction agent as it results in increased hemodynamic stability compared to propofol. This is seen as a major advantage in patients that frequently have a fragile haemodynamic situation.\n\nA major side effect of Etomidate is the resulting adrenal dysfunction, which hampers the bodies stress response and has been shown to cause a higher mortality in infectious contexts such as sepsis. It remains unclear to what extend this attenuated stress response has an impact on the post-operative context in cardiosurgical patients. First preliminary data show that patients receiving Etomidate as an induction agent are more prone to infection than those receiving a different agent, a definitive correlation is nevertheless still lacking.\n\nThis is a retrospective before-after-study comparing the rate of infectious complications in patients receiving either valve and/or coronary cardiac surgery at the Charité - Universitätsmedizin Berlin between October 1st, 2012 and January 31th, 2015. On October 1st, 2013 the standard operating procedures for anesthesia for cardiac surgery were amended and the induction agent at the Charité - Universitätsmedizin Berlin was switched from Etomidate to Propofol. The investigators are therefore comparing patients undergoing cardiac surgery between October 1st, 2012 and September 30th, 2013 as the Etomidate group with patients undergoing surgery between February 1st, 2014 and January 31st, 2015 as the Propofol group. The gap in between the two groups (October 1st, 2013 - January 31st, 2014) was defined as a washout phase to account for a potential delay in implementation of the renewed standard operating procedures. Patients will be investigated unmatched as well as matched according to (Age, Body Mass Index, American Society of Anesthesiologists physical status classification system (ASA), New York Heart Association Functional Classification (NYHA), Surgical Mode and Diabetes). The data for both groups will be acquired from the 2 electronic patient data management systems at our hospital (COPRA System, Sasbachwalden, Germany, and SAP, Walldorf, Germany).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that underwent cardiac surgery between October 1st, 2012 and January 31st, 2015', 'genderDescription': 'all gender are eligible.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Valve and/or coronary artery bypass graft surgery\n\nExclusion Criteria:\n\n* Surgery during washout period (October 1st, 2013 - January 31st, 2014)\n* Resurgery\n* Endocarditis\n* Known immunosuppression:\n* Corticosteroid therapy\n* Solid organ transplant\n* Stem Cell therapy\n* HIV diagnosis'}, 'identificationModule': {'nctId': 'NCT04281706', 'briefTitle': 'Impact of Etomidate vs. Propofol on Infectious Complications Post Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Impact of Etomidate vs. Propofol on Development of Sepsis and Infectious Complications Post Cardiac Surgery', 'orgStudyIdInfo': {'id': 'EtoProp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Etomidate-Time-Frame', 'description': 'Patients that underwent cardiac surgery between October 1st, 2012 and September 30th, 2013', 'interventionNames': ['Drug: Etomidate vs Propofol as induction agent']}, {'label': 'Propofol-Time-Frame', 'description': 'Patients that underwent cardiac surgery between February 1st, 2014 and January 31st, 2015', 'interventionNames': ['Drug: Etomidate vs Propofol as induction agent']}], 'interventions': [{'name': 'Etomidate vs Propofol as induction agent', 'type': 'DRUG', 'description': 'Patients undergoing cardiac surgery were induced with Etomidate according to the standard operating procedure for induction until October 1st, 2013, afterwards a new SOP with Propofol as primary induction agent was introduced. After a washout period of 3 months, Propofol was used as sole induction agent. The rest of the standard operating procedure remained the same.', 'armGroupLabels': ['Etomidate-Time-Frame', 'Propofol-Time-Frame']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt Universität zu Berlin and Berlin Institute of Health, Augustenburger Platz 1, 13353', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Prof. Dr. Dr. Felix Balzer, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Dr. Felix Balzer, MSc; ECDF-Professor for', 'investigatorFullName': 'Felix Balzer', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}