Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT04530760
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2020-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'abundant microaspiration', 'timeFrame': '48 hours after inclusion', 'description': 'presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'from ICU admission until day 28', 'description': 'number of death'}, {'measure': 'Incidence of ventilator associated pneumonia (VAP)', 'timeFrame': 'from intubation until day 28 or extubation', 'description': 'percentage of patients with VAP'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'from intubation until day 28 or extubation', 'description': 'number of days with mechanical ventilation'}, {'measure': 'incidence of patients requiring renal replacement therapy', 'timeFrame': 'from ICU admission until Day 28 or ICu discharge, whichever came first', 'description': 'percentage of patients with renal replacement treatment'}, {'measure': 'incidence of cirrhosis related complications', 'timeFrame': 'from ICU admission until Day 28 or ICU discharge, whichever came first', 'description': 'percentage of patients with cirrhosis related complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Cirrhosis, Liver']}, 'descriptionModule': {'briefSummary': 'The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.', 'detailedDescription': 'Intra-abdominal pressure monitoring will be performed using intra-vesical pressure every 8 hour in the first 2 days of mechanical ventilation.\n\nMicro aspiration is defined by pepsin or amylase positivity in trachea suction. Two groups will be compared : one with IAH , one without IAH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cirrhotic patients receiving invasive mechanical ventilation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* Cirrhosis\n* intubation and mechanical ventilation\n\nExclusion Criteria:\n\n* pregnancy\n* oliguric patients\n* impossibility to measure intravesical pressure'}, 'identificationModule': {'nctId': 'NCT04530760', 'acronym': 'ATOMIC', 'briefTitle': 'Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients', 'orgStudyIdInfo': {'id': '2018_75'}, 'secondaryIdInfos': [{'id': '2019-A02622-55', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'intraabdominal hypertension group', 'description': 'patients with intraabdominal hypertension defined as intravesical pressure more than 12 mmHg'}, {'label': 'control group', 'description': 'patients with no intraabdominal hypertension'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0320445962'}], 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0320445962'}], 'facility': 'Hop Salengro - Hopital B', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Saad Nseir, MD,PhD', 'role': 'CONTACT', 'email': 'saadalla.nseir@chru-lille.fr', 'phone': '0320444495', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Saad Nseir, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}