Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02799160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-18', 'releaseDate': '2024-07-28'}, {'resetDate': '2025-03-07', 'releaseDate': '2025-02-16'}], 'estimatedResultsFirstSubmitDate': '2024-07-28'}}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Ascites fluid, serum and plasma probes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-11', 'studyFirstSubmitDate': '2016-06-01', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change over time of stroke-volume (milliliter) before, under and after paracentesis', 'timeFrame': '10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis', 'description': 'Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis'}, {'measure': 'Change over time of arterial pressure (millimeter of mercury) before, under and after paracentesis', 'timeFrame': '10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis', 'description': 'Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse effects', 'timeFrame': 'Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis', 'description': 'Clinical, laboratory and haemodynamic adverse effects of paracentesis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Paracentesis']}, 'referencesModule': {'references': [{'pmid': '9247479', 'type': 'RESULT', 'citation': 'Ruiz-del-Arbol L, Monescillo A, Jimenez W, Garcia-Plaza A, Arroyo V, Rodes J. Paracentesis-induced circulatory dysfunction: mechanism and effect on hepatic hemodynamics in cirrhosis. Gastroenterology. 1997 Aug;113(2):579-86. doi: 10.1053/gast.1997.v113.pm9247479.'}, {'pmid': '15195901', 'type': 'RESULT', 'citation': 'Coll S, Vila MC, Molina L, Gimenez MD, Guarner C, Sola R. Mechanisms of early decrease in systemic vascular resistance after total paracentesis: influence of flow rate of ascites extraction. Eur J Gastroenterol Hepatol. 2004 Mar;16(3):347-53. doi: 10.1097/00042737-200403000-00016.'}, {'pmid': '8119542', 'type': 'RESULT', 'citation': 'Pozzi M, Osculati G, Boari G, Serboli P, Colombo P, Lambrughi C, De Ceglia S, Roffi L, Piperno A, Cusa EN, et al. Time course of circulatory and humoral effects of rapid total paracentesis in cirrhotic patients with tense, refractory ascites. Gastroenterology. 1994 Mar;106(3):709-19. doi: 10.1016/0016-5085(94)90706-4.'}, {'pmid': '12500206', 'type': 'RESULT', 'citation': 'Albillos A, de la Hera A, Gonzalez M, Moya JL, Calleja JL, Monserrat J, Ruiz-del-Arbol L, Alvarez-Mon M. Increased lipopolysaccharide binding protein in cirrhotic patients with marked immune and hemodynamic derangement. Hepatology. 2003 Jan;37(1):208-17. doi: 10.1053/jhep.2003.50038.'}]}, 'descriptionModule': {'briefSummary': 'This observational study evaluates the clinical, biochemical and haemodynamic effects of large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation', 'detailedDescription': 'Ascites is one of the common complications in advanced liver cirrhosis. Large-volume paracentesis (LVP) is a widely used symptomatic intervention to remove large amounts of peritoneal fluid. Despite a low rate of interventional-associated complications like fistula or non life-threatening bleeding LVP induces an impairment of circulatory function. The hypothesis is that haemodynamic changes can be detected by non-invasive monitoring and that these haemodynamic changes could be associated to postinterventional organ dysfunction or complications. Additionally the investigators hypothesize that paracentesis-induced circulatory dysfunction could also be associated to present clinical and laboratory signs of inflammation or infection and could influenced by increased viable and non-viable bacterial translocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the Medical Department, Division of Hepatology and Gastroenterology (including Metabolic Diseases)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male Patients between 18-70 years with liver cirrhosis and ascites\n* Indication for paracentesis\n\nExclusion Criteria:\n\n* Infectious disease in the last 4 weeks\n* Active alcohol-consumption or missing data of alcohol use\n* Missing inform consent\n* Missing speech comprehension\n* Neurological or psychiatric disease that compromise consenting\n* Hepatic encephalopathy stage III (West-Haven criteria)\n* Heart failure NYHA IV\n* Renal insufficiency or hepatorenal syndrome\n* Atrial fibrillation\n* Pacemaker'}, 'identificationModule': {'nctId': 'NCT02799160', 'acronym': 'Paracentesis', 'briefTitle': 'Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations', 'orgStudyIdInfo': {'id': 'EA2/052/16'}}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Wiedenmann Betram, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite Universitätsmedizin Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technische Universität Berlin', 'class': 'OTHER'}, {'name': 'Humboldt-Universität zu Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Dr. med. Donata Grajecki', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-28', 'type': 'RELEASE'}, {'date': '2024-10-18', 'type': 'RESET'}, {'date': '2025-02-16', 'type': 'RELEASE'}, {'date': '2025-03-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. med. Donata Grajecki, Dr. med., Charite University, Berlin, Germany'}}}}