Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06008067
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2023-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': 'Day 28', 'description': 'Mortality rate after at day 28.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Care', 'Septic Shock', 'Echocardiography', 'RV dysfunction'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '40307938', 'type': 'DERIVED', 'citation': 'Habib T, Ahmed I, Abayazeed R, Montasser M. The prognostic role of tricuspid annular plane systolic excursion in critically ill patients with septic shock. J Anesth Analg Crit Care. 2025 Apr 30;5(1):24. doi: 10.1186/s44158-025-00227-0.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the possible prognostic performance of RV dysfunction, as assessed by TAPSE, in non-cardiac patients with septic shock.', 'detailedDescription': 'The objective is to investigate the prognostic performance of right ventricular dysfunction, as assessed by tricuspid annular plane systolic excursion (TAPSE), in non-cardiac patients with septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3).\n\nExclusion Criteria:\n\n* Pregnant females\n* Trauma\n* Documented coronary heart disease\n* History of myocardial infarction\n* Myocarditis\n* Thrombo-embolic pulmonary disease\n* Valvular heart disease\n* Corpulmonale\n* Arrhythmia\n* Known left ventricular ejection fraction \\< 40%\n* Poor echocardiographic window'}, 'identificationModule': {'nctId': 'NCT06008067', 'briefTitle': 'The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock', 'orgStudyIdInfo': {'id': 'TAPSESEPTIC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survivors', 'description': 'Patients who survived after day 28.', 'interventionNames': ['Radiation: tricuspid annular plane systolic excursion (TAPSE)']}, {'label': 'Non-survivors', 'description': 'Patients who died at or before day 28.', 'interventionNames': ['Radiation: tricuspid annular plane systolic excursion (TAPSE)']}], 'interventions': [{'name': 'tricuspid annular plane systolic excursion (TAPSE)', 'type': 'RADIATION', 'description': 'Echocardiography', 'armGroupLabels': ['Non-survivors', 'Survivors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Alexandria University Hospitals', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Tamer Habib, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}