Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-02 @ 12:37 AM
Study NCT ID:
NCT03969966
Status:
UNKNOWN
Last Update Posted:
2020-05-11
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Citrate Anticoagulation for Postdilution Hemofiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-05-29', 'lastUpdatePostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Filter running time', 'timeFrame': '72 hours', 'description': 'Filterlifetime with regional citrate anticoagulation for haemofiltration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '38982339', 'type': 'DERIVED', 'citation': 'Dimski T, Brandenburger T, Vollmer C, Kindgen-Milles D. A safe and effective protocol for postdilution hemofiltration with regional citrate anticoagulation. BMC Nephrol. 2024 Jul 9;25(1):218. doi: 10.1186/s12882-024-03659-y.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.', 'detailedDescription': 'Acute kidney injury (AKI) requiring continuous renal replacement therapy (CCRT occurs in approx. 15 % of all intensive care patients. A sustained and prolonged filter running time is required to deliver an effective dialysis dose. This requires effective anticoagulation. Today, regional citrate anticoagulation (RCA) is preferred over systemic anticoagulation because of prolonged filter lifetimes and less adverse effects.\n\nWe here study prospectively patients with AKI who are treated with continuous veno-venous haemofiltration using an RCA protocol.\n\nWe will evaluate all parameters of CRRT including filter running times, delivered dialysis dose, causes for treatment interruption and control of pH and electrolytes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients at ICU with acute kidney injury', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute kidney injury\n* critical illness and treatment at ICU\n\nExclusion Criteria:\n\n* age \\< 18 years\n* pregnancy or breast feeding\n* severe lactate acidosis ( \\> 10 mmol/l) for longer than 6 hours and pH \\< 7.2'}, 'identificationModule': {'nctId': 'NCT03969966', 'acronym': 'CIPOHA', 'briefTitle': 'Citrate Anticoagulation for Postdilution Hemofiltration', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Citrate Anticoagulation for Postdilution Hemofiltration', 'orgStudyIdInfo': {'id': '2018-82'}}, 'armsInterventionsModule': {'interventions': [{'name': 'renal replacement therapy as clinically indicated', 'type': 'OTHER', 'description': 'Continuous renal replacement therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kindgen-Milles, MD', 'role': 'CONTACT', 'email': 'kindgen-milles@med.uni-duesseldorf.de', 'phone': '+49 211 81', 'phoneExt': '07049'}, {'name': 'Detlef Kindgen-Milles, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Timo Brandenburger, PD Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Dimski, Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Diamed GmbH, Cologne, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. D. Kindgen-Milles', 'investigatorFullName': 'Klinik für Anästhesiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}