Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06160856
Status:
UNKNOWN
Last Update Posted:
2023-12-07
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}, {'id': 'D006940', 'term': 'Hyperemia'}], 'ancestors': [{'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-11-29', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure)', 'timeFrame': '01.12.2023 - 01.08.2024'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intra-Abdominal Hypertension', 'Venous Congestion']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective observational study is to examine the potential association between intra-abdominal pressure and venous congestion as assessed by abdominal ultrasound, in critically ill patients in the Intensive Care Unit (ICU).\n\nThe main question it aims to answer is whether there is association between intra-abdominal pressure and Venous Excess Ultrasound (VExUS) score.\n\nParticipants will be sonographically assessed and their intra-abdominal pressure measured once within the first 3 days of ICU admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive adult patients admitted in a 31-bed University-affiliated general ICU in a tertiary hospital (Evangelismos General Hospital, Athens, Greece). The ICU admitts both medical and surgical patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated ICU patients on controlled mechanical ventilation, receiving sedation. Patients must have urethral catheter in place.\n\nExclusion Criteria:\n\n* age \\< 18 year old\n* pregnancy / lactation\n* primary liver disease (hepatic cirrhosis, hepatic space-occupying lesions, Budd-Chiari syndrome, portal vein thrombosis) or hepatic surgery\n* end stage renal failure or on chronic dialysis\n* non-intubated patients or intubated patients on non-controlled mechanical ventilation mode\n* absence of urethral catheter, presence of suprapubic catheter, continuous bladder irrigation\n* poor abdominal echogenicity'}, 'identificationModule': {'nctId': 'NCT06160856', 'briefTitle': 'Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.', 'orgStudyIdInfo': {'id': '35656'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal intra-abdominal pressure', 'interventionNames': ['Diagnostic Test: Abdominal ultrasound']}, {'label': 'Elevated intra-abdominal pressure', 'interventionNames': ['Diagnostic Test: Abdominal ultrasound']}], 'interventions': [{'name': 'Abdominal ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['VExUS score calculation'], 'description': 'Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score', 'armGroupLabels': ['Elevated intra-abdominal pressure', 'Normal intra-abdominal pressure']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kyriakos K. Trigkidis, MD', 'role': 'CONTACT', 'email': 'k.trigkidis@gmail.com', 'phone': '+30697843660'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Kyriakos K. Trigkidis', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}