Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-26 @ 12:10 AM
Study NCT ID:
NCT01077895
Status:
WITHDRAWN
Last Update Posted:
2022-12-15
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014462', 'term': 'Ultrafiltration'}], 'ancestors': [{'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005374', 'term': 'Filtration'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-02-26', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IAP in patients receiving fluid removal during CVVH vs patients receiving CVVH without net fluid removal after 24 and 48h of CVVH treatment', 'timeFrame': '24 and 48 hours'}], 'secondaryOutcomes': [{'measure': 'Difference between CVVH with fluid removal and CVVH without fluid removal', 'timeFrame': 'after 24 hours and/or 7 days', 'description': 'Difference in terms of\n\n* Need for vasopressor medication and hemodynamic parameters during the first seven days\n* PaO2/FiO2 (worst value over 24h daily first 7 days)\n* Volume of albumin solution or synthetic colloids administered during CVVH per 24h\n* SOFA score daily first seven days\n* Need for decompressive laparotomy or other means to decrease IAP\n* Acid-base status\n* Complications relating to ischemia'}, {'measure': 'Difference between both groups in terms of daily fluid balance', 'timeFrame': 'during 7 days'}, {'measure': 'The relationship between cumulative fluid balance at the start of each day of CVVH and the fluid balance achieved after 24h of CVVH with fluid removal', 'timeFrame': '24 hours'}, {'measure': 'Difference between both groups regarding recovery of renal function, need for RRT at discharge from the ICU and from the hospital', 'timeFrame': 'discharge from ICU and hospital'}, {'measure': 'Difference between both groups regarding mortality (28d, ICU and hospital) and ICU and hospital length of stay', 'timeFrame': '28 days and length of stay in ICU and hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Critically ill patients with positive fluid balance, IAH and AKI requiring RRT'], 'conditions': ['Critically Ill', 'Intra-Abdominal Hypertension', 'Abdominal Compartment Syndrome', 'Acute Kidney Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Intra- abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are a cause of organ dysfunction in critically ill patients. IAH develops due to abdominal lesions (primary IAH) or extra-abdominal processes (secondary IAH). Secondary IAH arises due to decreased abdominal wall compliance and gut edema caused by capillary leak and excessive fluid resuscitation. Decreasing intra-abdominal pressure (IAP) using decompressieve laparotomy has been shown to improve organ dysfunction. However, laparotomy is generally avoided in patients with secondary IAH due to the risk of abdominal complications.\n\nAcute kidney injury (AKI) is one of the first and most pronounced organ failures associated with IAH and many patients with AKI in the ICU require renal replacement therapy (RRT). Fluid removal using continuous RRT (CRRT) has been demonstrated to decrease IAP in small series and selected patients.\n\nThe aim of this study is to evaluate whether fluid removal using CVVH in patients with IAH, fluid overload and AKI is feasible and whether it has a beneficial effect on organ dysfunction (compared to CVVH without net fluid removal).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18y old) of either gender\n* Admitted to the ICU\n* Sedated and mechanically ventilated (and expected to remain so for at least 48h)\n* Informed consent given\n* admitted to the ICU for \\<7 days or during the first 7 days of a new shock episode\n* AKI requiring RRT according to treating physician\n* IAP \\>12mmHg being attributed to fluid overload by treating physician\n\nExclusion Criteria:\n\n* Included in the same study before\n* Vasopressor and/or inotrope dose needed above noradrenaline 1µg/kg/min and dobutamine 10µg/kg/min\n* PaO2/FiO2 ratio \\<100'}, 'identificationModule': {'nctId': 'NCT01077895', 'briefTitle': 'The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function in Critically Ill Adults With Intra-abdominal Hypertension and Acute Kidney Injury', 'orgStudyIdInfo': {'id': '2009/721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVVH with fluid removal', 'interventionNames': ['Procedure: CVVH', 'Procedure: ultrafiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CVVH without fluid removal', 'interventionNames': ['Procedure: CVVH', 'Procedure: ultrafiltration control group']}], 'interventions': [{'name': 'CVVH', 'type': 'PROCEDURE', 'description': 'CVVH is started using following parameters:\n\n* Blood flow is started at 150 mL/min\n* Anticoagulation: none, heparin or low molecular weight heparin according to local protocols in study centers.\n* In both groups: dialysis dose of 25 mL/kg body weight administered using both pre- and postdilution\n* Substitution fluid temperature is started at 37°C and adjusted in function of patient body temperature (which is maintained at 35-37°C)', 'armGroupLabels': ['CVVH with fluid removal', 'CVVH without fluid removal']}, {'name': 'ultrafiltration', 'type': 'PROCEDURE', 'description': 'ultra filtration is started at 100 mL/h and increased according to following protocol\n\n* Ultrafiltration is increased by 100 mL/h after 2h and subsequently by 100mL/h (until a maximum of 500mL/h) every 4h unless:\n* Vasopressor or inotrope medication dose is increased by \\> 25% (provided mean arterial pressure remains constant at 65 mmHg or another target value specified by treating physician according to standard of care)\n* When above condition is not met UF should be kept constant and a passive leg raising test or stroke volume variation measurement should be performed. If SVV \\> 10% or PLR is positive 100mL of albumin 20% solution or 250 mL of Hydroxyethyl Starch 130/0.4 solution is administered according to treating physician at a maximum of 4 times per 24h\n* If there is no improvement after 2 colloid administration rounds, UF should be stopped for 4h and restarted at half the rate it was set at when discontinued.', 'armGroupLabels': ['CVVH with fluid removal']}, {'name': 'ultrafiltration control group', 'type': 'PROCEDURE', 'description': 'ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)', 'armGroupLabels': ['CVVH without fluid removal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Stuivenberg Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'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, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stuivenberg Hospital Antwerp', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}