Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-21 @ 9:53 PM
Study NCT ID:
NCT03663192
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2018-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strain Echocardiography During Septic Shock : an Observational Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], '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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain', 'timeFrame': 'up to 90 days'}], 'secondaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'up to 90 days', 'description': 'On the day of patient discharge from the ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shock, Septic', 'Echocardiography', 'speckle tracking', 'strain'], 'conditions': ['Shock, Septic', 'Echocardiography']}, 'referencesModule': {'references': [{'pmid': '33216237', 'type': 'RESULT', 'citation': 'Bazalgette F, Roger C, Louart B, Daurat A, Bobbia X, Lefrant JY, Muller L. Prognostic value and time course evolution left ventricular global longitudinal strain in septic shock: an exploratory prospective study. J Clin Monit Comput. 2021 Dec;35(6):1501-1510. doi: 10.1007/s10877-020-00620-w. Epub 2020 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.\n\nIn the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min)\n* Inclusion within the first 24h of septic shock\n\nExclusion Criteria:\n\n* Patient \\< 18 year of age\n* Pregnant women\n* History of myocardial infarction, valvular disease, atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT03663192', 'acronym': 'Sepsistrain', 'briefTitle': 'Strain Echocardiography During Septic Shock : an Observational Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Strain Echocardiography During Septic Shock : an Observational Pilot Study', 'orgStudyIdInfo': {'id': 'IRB : 16.02.07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'strain echocardiography', 'type': 'DEVICE', 'description': 'strain echocardiography during septic shock'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Intensive care unit CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Claire Roger, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}