Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT04055727
Status:
UNKNOWN
Last Update Posted:
2021-11-12
First Post:
2019-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sepsis at Södersjukhuset-Adherence to Treatment Guidelines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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': 'ESTIMATED', 'count': 11000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gender differences in 90-day mortality', 'timeFrame': '90 days', 'description': 'Gender differences in percentage of patients who died before day 90'}], 'secondaryOutcomes': [{'measure': 'Association between adherence to treatment guidelines and mortality', 'timeFrame': '90 days', 'description': 'Association between number of completed sepsis bundles and mortality'}, {'measure': 'Incidence of sepsis', 'timeFrame': '90 days', 'description': 'Number of patients admitted to the Emergency Department at Södersjukhuset during the study period comparing to the hospitals catchment area'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treatment'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.', 'detailedDescription': 'In this single-center study, patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years will be included. About 11,000 patients will be included. Patient data including described sepsis symptoms will be drawn from the electronic medical record, TakeCare and Clinisoft. Logistic regression analysis will adjust for age, gender, comorbidity according to Charlson score, vital signs, with preliminary focus of infection (pneumonia, urinary tract infection, abdominal, other, unknown). The Surviving Sepsis guidelines for the time period are: 3-hour bundle including lactate measurement, obtaining blood culture, fluid treatment if hypotensive and administration of broad-spectrum antibiotics. The 6-hour bundles with administration of vasopressors if needed, remeasure lactate if elevated, with persistent hypotension re-asses volume status and tissue perfusion. Time zero is defined as the admission time to the emergency department. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the emergency department at Södersjukhuset', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n• Patients admitted to the Emergency Department at Södersjukhuset with suspicion of sepsis defined as blood cultures taken and intravenous antibiotics of type beta-lactam or aminoglycoside prescribed within 48 hours of admission.\n\nExclusion criteria:\n\n• Patients transferred from other hospitals or treatment clinics.'}, 'identificationModule': {'nctId': 'NCT04055727', 'briefTitle': 'Sepsis at Södersjukhuset-Adherence to Treatment Guidelines', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Sepsis at Södersjukhuset-Adherence to Treatment Guidelines', 'orgStudyIdInfo': {'id': 'SepsisSoS'}}, 'contactsLocationsModule': {'locations': [{'zip': '11880', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Katarina Bohm, Ass Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Katarina Bohm', 'investigatorAffiliation': 'Karolinska Institutet'}}}}