Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT03650660
Status:
TERMINATED
Last Update Posted:
2025-12-03
First Post:
2018-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'departure of the principal recruiter in the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training', 'timeFrame': '48 hours', 'description': 'Difference in measured Left Ventricular Ejection Fraction (%)'}, {'measure': "Concordance in E' wave at the lateral mitral ring and mitral E wave measurement by expert versus a non-specialist gastroenterologist with standard training", 'timeFrame': '48 hours', 'description': "Difference in measured E / E' ratio"}, {'measure': 'Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training', 'timeFrame': '48 hours', 'description': 'Difference in measured velocity-time integral (cm)'}], 'secondaryOutcomes': [{'measure': 'Death rate', 'timeFrame': 'Day 28'}, {'measure': 'Duration of hospitalization', 'timeFrame': 'End of follow-up (maximum 28 days)'}, {'measure': 'Number of admissions to intensive care', 'timeFrame': 'End of follow-up (maximum 28 days)'}, {'measure': 'Consummation of diuretics', 'timeFrame': 'Day 0'}, {'measure': 'albumin infusion necessity', 'timeFrame': 'Day 0'}, {'measure': 'Use of vasopressors', 'timeFrame': 'Day 0'}, {'measure': 'auto ejection fraction measurement on trans-thoracic ultrasound by expert', 'timeFrame': 'Day 0', 'description': 'Doppler'}, {'measure': 'lateral mitral annulus measurement on trans-thoracic ultrasound by expert', 'timeFrame': 'Day 0', 'description': 'Doppler'}, {'measure': 'Mitral E wave measurement on trans-thoracic ultrasound by expert', 'timeFrame': 'Day 0', 'description': 'Doppler'}, {'measure': 'Mitral A wave measurement on trans-thoracic ultrasound by expert', 'timeFrame': 'Day 0', 'description': 'Doppler'}, {'measure': 'Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expert', 'timeFrame': 'Day 0', 'description': 'Doppler'}, {'measure': 'Presence of intrapulmonary shunt', 'timeFrame': 'Day 0', 'description': 'Y/N'}, {'measure': 'Presence of aortic stenosis', 'timeFrame': 'Day 0', 'description': 'Y/N'}, {'measure': 'Presence of mitral insufficiency', 'timeFrame': 'Day 0', 'description': 'Y/N'}, {'measure': 'Presence of mitral stenosis', 'timeFrame': 'Day 0', 'description': 'Y/N'}, {'measure': 'left atrium surface area', 'timeFrame': 'Day 0', 'description': 'cm2'}, {'measure': 'left ventricle diameter', 'timeFrame': 'Day 0', 'description': 'mm'}, {'measure': 'Septal wall thickness', 'timeFrame': 'Day 0', 'description': 'mm'}, {'measure': 'Posterior wall thickness', 'timeFrame': 'Day 0', 'description': 'mm'}, {'measure': 'tricuspid annular plane systolic excursion', 'timeFrame': 'Day 0', 'description': 'mm'}, {'measure': 'tricuspid annular plane systolic velocity', 'timeFrame': 'Day 0', 'description': 'cm/s'}, {'measure': 'heart chamber dilation', 'timeFrame': 'Day 0'}, {'measure': 'pulmonary arterial hypertension', 'timeFrame': 'Day 0', 'description': 'mmHg'}, {'measure': 'Pericardial effusion', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhoses']}, 'referencesModule': {'references': [{'pmid': '36840793', 'type': 'RESULT', 'citation': 'Prost A, Bourgaux JF, Louart B, Caillo L, Daurat A, Lefrant JY, Pouderoux P, Muller L, Roger C. Echocardiographic hemodynamic assessment in decompensated cirrhosis: comparison between Intensivists and Gastroenterologists. J Clin Monit Comput. 2023 Oct;37(5):1219-1228. doi: 10.1007/s10877-023-00983-w. Epub 2023 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cirrhosis patients admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be an adult at least 18 years old\n* Patient has known or suspected cirrhosis (diagnosed by biopsy or based on recognized clinical/biological/radiological criteria)\n* Admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient is pregnant or breastfeeding\n* Patient already participated in the study\n* Patient with cirrhosis admitted for a different decompensation (active digestive hemorrhage or sepsis)\n* Poorly echogenic patient\n* Patient withdraws consent\n* Patient with anasarca of cardiac origin\n* Ultrasound diagnosis of a severe cardiac pathology requiring specialized treatment in intensive care or cardiology (severe cardiac insufficiency, acute pulmonary edema, endocarditis, severe valvulopathy, cardiac tamponade, intracardiac thrombus)'}, 'identificationModule': {'nctId': 'NCT03650660', 'acronym': 'EchoCirrho', 'briefTitle': 'Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist', 'orgStudyIdInfo': {'id': 'Local/2017/JFB-01'}, 'secondaryIdInfos': [{'id': '2017-A03144-49', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with liver cirrhosis', 'interventionNames': ['Other: Trans-thoracic ultrasound']}], 'interventions': [{'name': 'Trans-thoracic ultrasound', 'type': 'OTHER', 'description': 'Trans-thoracic ultrasound performed by an expert and a non-expert', 'armGroupLabels': ['Patients with liver cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Jean François Bourgaux', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}