Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
Study NCT ID:
NCT06756750
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2024-12-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Risk Factors for In-Hospital Mortality in Surgical Patients With Abdominal Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'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': 476}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2024-12-27', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'January 2008 - December 2022'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal sepsis', 'surgical patients', 'risk factors', 'general anesthesia', 'retrospective'], 'conditions': ['Sepsis', 'Glucocorticoid']}, 'descriptionModule': {'briefSummary': 'A retrospective study of sepsis patients with abdominal infections who underwent abdominal surgery was conducted in an attempt to reveal the epidemiological characteristics of sepsis after abdominal surgery, risk factors, and to analyze the prognosis of the patients, to reveal indicators of predictive value for the prognosis of patients with sepsis, with a view to providing certain evidence for optimizing the perianesthesia management of patients with sepsis.', 'detailedDescription': 'Background and Aims: Abdominal sepsis refers to a severe and potentially life-threatening condition characterized by the presence of infection, inflammation, and tissue damage within the abdominal cavity. Glucocorticoids (GCs) play an important role in regulation of the host immune and inflammation responses involved in sepsis and surgery. This study aimed to investigate the potential impact of intraoperative GCs administration on the clinical outcome of surgical patients with abdominal sepsis.\n\nMethods: This retrospective cohort study included a 1:1 propensity score-matched cohort of surgical patients afflicted with abdominal sepsis at 2 medical centers from January, 2008, through December, 2022. Patients were classified into low-GCs, high-GCs, and non-GCs groups according to the dosage of steroids used intraoperatively, and in-hospital mortality was designated as the primary outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Abdominal septic patients underwent surgical procedures in two large-scale medical centers (the First Medical Center of the Chinese People's Liberation Army \\[PLA\\] General Hospital and the Air Force Medical Center) between Jan, 2008 and Dec, 2022 in Beijing, China.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meeting the Sepsis 3.0 criteria ;\n* Patient's age ≥ 18 years;\n* Emergency or elective abdominal surgery.\n\nExclusion Criteria:\n\n* History of severe cardiopulmonary, hepatic, renal, or other organ damage;\n* Preoperative presence of infection other than abdominal;\n* Unplanned secondary surgery；\n* Receiving preoperative glucocorticoid therapy."}, 'identificationModule': {'nctId': 'NCT06756750', 'briefTitle': 'Clinical Characteristics and Risk Factors for In-Hospital Mortality in Surgical Patients With Abdominal Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Intraoperative Low-dose Glucocorticoids in Surgical Patients With Abdominal Sepsis: A Multicenter Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'PLAGH-AOC-L06'}}, 'contactsLocationsModule': {'locations': [{'zip': '100853/100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital /Depatment of Anesthesiology, The Air Force Medical Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Weidong Mi', 'role': 'STUDY_CHAIR', 'affiliation': 'Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jingsheng Lou', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}