Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-09 @ 1:58 AM
Study NCT ID:
NCT01091233
Status:
WITHDRAWN
Last Update Posted:
2021-07-08
First Post:
2010-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D001201', 'term': 'Ascites'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019152', 'term': 'Paracentesis'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'logistical problems', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2010-03-19', 'studyFirstSubmitQcDate': '2010-03-22', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis', 'timeFrame': '24h after paracentesis', 'description': 'Kidney function parameters include 2h creatinine clearance, serum and urine creatinine, renal artery resistive index (measured via color Doppler), urinary output, serum cystatine C and NGAL measurement.'}], 'secondaryOutcomes': [{'measure': 'The association between the change in IAP and kidney function', 'timeFrame': '24h after paracentesis'}, {'measure': 'The relationship between the amount of fluid drained and any effect on IAP and kidney function', 'timeFrame': '24h after paracentesis'}, {'measure': 'Cystatin C, NGAL, creatinine clearance, serum creatinine, urinary output and RI as measures of kidney injury in patients with liver cirrhosis and ascites', 'timeFrame': '24h after paracentesis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Critically ill patients', 'liver cirrhosis', 'ascites requiring Paracentesis'], 'conditions': ['Critically Ill', 'Liver Cirrhosis', 'Ascites']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Patients with liver cirrhosis are at risk for development of renal failure, usually after a precipitating event such as infection or bleeding. This form of renal failure has a high morbidity and mortality and may be partly caused by increased intra-abdominal pressure secondary to ascites. Recent studies have shown that paracentesis (and the resulting decreased IAP) can increase urinary output and decrease renal arterial resistive index in patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis patients). The aim of this study is to evaluate the influence of Paracentesis on intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis and ascites across a wider range of kidney function. Kidney function will be evaluated using several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients with liver cirrhosis and ascites requiring Paracentesis according to treating physician', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* \\>18 y old\n* Admitted to the ICU\n* Known liver cirrhosis with ascites on clinical examination and/or ultrasound\n* Sedated and mechanically ventilated\n* Paracentesis deemed necessary by treating physician\n* Arterial and central venous catheter in place\n* Urinary catheter in place\n\nExclusion criteria:\n\n* Previous inclusion in the same study\n* Renal replacement therapy in place\n* Urinary catheter contra-indicated\n* Use of radiocontrast media within 72h before paracentesis'}, 'identificationModule': {'nctId': 'NCT01091233', 'briefTitle': 'The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study', 'orgStudyIdInfo': {'id': '2009/722'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paracentesis', 'description': 'Paracentesis as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)', 'interventionNames': ['Procedure: paracentesis']}], 'interventions': [{'name': 'paracentesis', 'type': 'PROCEDURE', 'description': 'as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)', 'armGroupLabels': ['Paracentesis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Eric Hoste, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}