Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 12:24 PM
Study NCT ID:
NCT03545750
Status:
UNKNOWN
Last Update Posted:
2019-11-25
First Post:
2018-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Replacement Anticoagulant Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '90-days', 'description': 'All-cause mortality 90 days after first ICU admission in which CRRT was received'}, {'measure': 'Incremental net monetary benefit', 'timeFrame': '1-year', 'description': 'Incremental net monetary benefit gained at one year'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30-days, and 1-year after ICU admission', 'description': 'All-cause mortality at hospital discharge, 30 days and one year after ICU admission'}, {'measure': 'Days of renal, cardiovascular, and advanced respiratory support whilst in ICU', 'timeFrame': 'Up to 5 years', 'description': 'Total number of days receiving renal, cardiovascular, and advanced respiratory support'}, {'measure': 'Bleeding and thromboembolic episodes', 'timeFrame': 'During index admission', 'description': 'Occurrence of bleeding and thromboembolic episodes'}, {'measure': 'ICU and hospital length of stay', 'timeFrame': 'Up to 5 years', 'description': 'Length of stay in hospital and ICU'}, {'measure': 'Dialysis-dependent renal disease', 'timeFrame': '1-year', 'description': 'Identification of new dialysis-dependent renal disease at 1-year assessed by data linkage with UK Renal Registry'}, {'measure': 'Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT', 'timeFrame': 'at 5 years', 'description': 'Lifetime Incremental net monetary benefit gained'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney injury', 'Continuous renal replacement therapy', 'Citrate', 'Heparin'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '36033243', 'type': 'DERIVED', 'citation': 'Gould DW, Doidge J, Zia Sadique M, Borthwick M, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Mouncey PR, Ostermann M, Harrison DA, Rowan KM, Duncan Young J, Watkinson PJ. Renal replacement anticoagulant management: Protocol and analysis plan for an observational comparative effectiveness study of linked data sources. J Intensive Care Soc. 2022 Aug;23(3):311-317. doi: 10.1177/1751143720913417. Epub 2020 Apr 2.'}, {'pmid': '35212260', 'type': 'DERIVED', 'citation': 'Gould DW, Doidge J, Sadique MZ, Borthwick M, Hatch R, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Ostermann M, Mouncey PR, Harrison DA, Rowan KM, Young JD, Watkinson PJ. Heparin versus citrate anticoagulation for continuous renal replacement therapy in intensive care: the RRAM observational study. Health Technol Assess. 2022 Feb;26(13):1-58. doi: 10.3310/ZXHI9396.'}]}, 'descriptionModule': {'briefSummary': 'Observational comparative effectiveness study of individual patient data using interrupted time series analysis techniques of linked data sources to establish clinical and health economic effects of moving from systemic heparin anticoagulation to regional citrate anticoagulation during continuous renal replacement therapy (CRRT) for patients treated on non-specialist Intensive Care Units (ICUs) in England and Wales.', 'detailedDescription': 'RRAM is an observational comparative effectiveness and cost-effectiveness study of individual patient data using interrupted time series analysis techniques and linked data sources. This study will use existing high quality clinical data collected for the Case Mix programme (CMP) - the national clinical audit for adult critical care - linked with Hospital Episodes Statistics, Office for National Statistics, and UK Renal Registry national data sets to establish the clinical and health economic effects of moving from systemic heparin anticoagulation (SHA) to regional citrate anticoagulation (RCA) during CRRT for patients treated on non-specialist ICUs in England and Wales. This will include data from approximately 85,000 patients treated with CRRT between 1 April 2009 and 31 March 2017 in 184 English non-specialist intensive care units within the ICNARC CMP.\n\nSpecific objectives of the RRAM are to:\n\n1. Investigate the short-term benefits, risks, and costs of citrate anticoagulation.\n2. Provide information on the subsequent development of end-stage renal disease (ESRD).\n3. Trial the efficient research techniques, that if successful could be used to track the effects of any change in critical care practice occurring in ICUs in England and Wales over a reasonably short time scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill adults who received CRRT on one or more day whilst treated on an ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16 years or greater\n* Admitted to an ICU participating in the ICNARC Case Mix Programme (CMP) in England between 1 April 2009 and 31st March 2017\n\nExclusion Criteria:\n\n* Pre-existing end-stage renal disease (ESRD)\n* Admitted to an ICU after kidney or kidney-pancreas transplantation\n* Primary admission with acute hepatic failure'}, 'identificationModule': {'nctId': 'NCT03545750', 'acronym': 'RRAM', 'briefTitle': 'Renal Replacement Anticoagulant Management', 'organization': {'class': 'OTHER', 'fullName': 'Intensive Care National Audit & Research Centre'}, 'officialTitle': 'Renal Replacement Anticoagulant Management', 'orgStudyIdInfo': {'id': 'ICNARC/02/08/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regional citrate anticoagulation (RCA)', 'description': 'Those receiving regional citrate anticoagulation for CRRT'}, {'label': 'Systemic heparin anticoagulation (SHA)', 'description': 'Those receiving systemic heparin anticoagulation for CRRT'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1V 6AZ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Intensive Care National Audit and Research Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Peter Watkinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'An anonymised study dataset will be availablefrom ICNARC on request to the Chief Investigator, subject to any necessary approvals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intensive Care National Audit & Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}, {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University of Bristol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}