Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 12:23 PM
Study NCT ID:
NCT01228292
Status:
UNKNOWN
Last Update Posted:
2010-10-26
First Post:
2010-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-25', 'studyFirstSubmitDate': '2010-10-25', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.', 'timeFrame': '6 hours after starting dialysis'}], 'secondaryOutcomes': [{'measure': 'The incidence of technique failure defined as the number of patients who develop a contra-indication for the allocated anticoagulation regimen during the study period', 'timeFrame': 'during whole wtudy'}, {'measure': 'The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria', 'timeFrame': 'during the whole study period'}, {'measure': 'The transfusion requirements defined as the total of units blood products administrated during the ICU stay and per dialysis treatment', 'timeFrame': 'during the whole study period'}, {'measure': 'The incidence of metabolic derangements during the study period', 'timeFrame': 'during the whole study period', 'description': '* Metabolic alkalosis (defined as a pH \\> 7,5 and a bicarbonate \\> 24 mmol/l)\n* Metabolic acidosis (defined as a pH \\< 7,25 and a bicarbonate \\< 18 mmol/l)\n* Hypocalcemia (defined as an ionized calcium \\< 0,9 mmol/l)\n* Hypercalcemia (defined as an ionized calcium \\> 1,2 mol/l)\n* Hypernatremia (defined as a Na+ \\> 145 mmol/l)\n* Hyponatremia (defined a a Na+ \\< 130 mmol/l)\n* Citrate toxicity (defined as a total calcium/ionized calcium ratio \\> 2,5)'}, {'measure': 'Dialysis efficiency expressed as Kt/V and URR', 'timeFrame': '6 hours after starting dialysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anticoagulation', 'Intensive Care Medicine', 'Hemodialysis', 'Critical Ill Patients'], 'conditions': ['Acute Kidney Injury', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '33314078', 'type': 'DERIVED', 'citation': 'Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill Patients.', 'detailedDescription': 'Objective : To compare the feasibility, safety and efficacy of Sustained Low Efficiency Daily Hemodialysis (SLEDD) using regional anticoagulation with Citrasate® compared to systemic anticoagulation with unfractionated heparin in critically ill patients.\n\nDesign : Prospective, randomized, single-center clinical trial Setting : mixed medical-surgical 45 bed ICU in a tertiary university hospital Patients : 250 patients with Acute Kidney Injury (AKI) stage III needing renal replacement therapy Interventions : Patients are randomized to receive SLEDD using standard dialysate and systemic anticoagulation with UF versus SLEDD using Citrasate®-dialysate with no additional UF.\n\nMeasurements and main results :\n\nPrimary end point :\n\n\\- The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.\n\nSecondary end points :\n\n* The incidence of bleeding episodes as defined by the WHO-criteria\n* The transfusion requirements\n* The incidence of technique failure\n* The incidence of metabolic derangements (metabolic alkalosis, metabolic acidosis, hypocalcemia, hypercalcemia, hypernatremia, hyponatremia)\n* The incidence of citrate intoxication\n* The dialysis efficiency expressed as Kt/V and URR\n\nTertiary end points :\n\n\\- All cause mortality at day 28 and day 90 after inclusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for hemodialysis in the ICU for at least one treatment\n* No prior hemodialysis treatment in the ICU except continuous renal replacement therapy\n\nExclusion Criteria:\n\n* Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons\n* Need for continued thrombolysis therapy within the 6 hours before inclusion\n* Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion\n* Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion\n* Liver failure (acute and acute-on-chronic)\n* Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)\n* Heparin allergies\n* Severe uncorrected hypocalcemia (ionized calcium \\< 0,8 mmol/l)\n* Refusal of informed consent'}, 'identificationModule': {'nctId': 'NCT01228292', 'briefTitle': 'Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.', 'orgStudyIdInfo': {'id': '10/27/179'}, 'secondaryIdInfos': [{'id': '2010-021665-68', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Anticoagulation', 'description': 'Hemodialysis is performed using standard anticoagulation using unfractionated heparin if no contra-indications for the use of heparin exist. If contra-indications for heparin exist a heparin coated hemofilter (Evodial) will be used. The use of unfractionated heparin or no heparin (with coated hemofilter) is a decision to be taken before every hemodialysis.', 'interventionNames': ['Drug: Unfractionated heparin']}, {'type': 'EXPERIMENTAL', 'label': 'Citrasate', 'description': 'Hemodialysis is performed with Citrasate', 'interventionNames': ['Drug: Citrasate']}], 'interventions': [{'name': 'Unfractionated heparin', 'type': 'DRUG', 'otherNames': ['Unfractionated Heparin, LEO laboratories Ltd, MA #PL 0043/0041R'], 'description': 'dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis', 'armGroupLabels': ['Standard Anticoagulation']}, {'name': 'Citrasate', 'type': 'DRUG', 'otherNames': ['Citrasate, Advanced Renal Technologies, MA #K000792'], 'description': 'Citrasate is infused as a dialysate', 'armGroupLabels': ['Citrasate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Edegem', 'country': 'Belgium', 'contacts': [{'name': 'Walter Verbrugghe, MD', 'role': 'CONTACT', 'email': 'walter.Verbrugghe@uza.be', 'phone': '003238214149'}, {'name': 'Philippe Jorens, PhD, MD', 'role': 'CONTACT', 'email': 'philippe.jorens@uza.be', 'phone': '003238213639'}], 'facility': 'Critical Care Department of the Antwerp University Hospital, Belgium', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Walter Verbrugghe, MD', 'role': 'CONTACT', 'email': 'walter.verbrugghe@uza.be', 'phone': '003238214149'}, {'name': 'Philippe Jorens, PhD, MD', 'role': 'CONTACT', 'email': 'philippe.jorens@uza.be', 'phone': '003238213639'}], 'overallOfficials': [{'name': 'Karin Jansen-Van doorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff member Nephrology Department'}, {'name': 'Gert Verpooten, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Nephrology Department, University Hospital Antwerp, Belgium'}, {'name': 'Walter Verbrugghe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff member Critical Care Department, Antwerp University Hospital, Belgium'}, {'name': 'Philippe Jorens, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Critical Care Department, Antwerp University Hospital, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Walter Verbrugghe', 'oldOrganization': 'Critical Care Physician'}}}}