Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02200120
Status:
COMPLETED
Last Update Posted:
2015-07-21
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2014-07-23', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dialysis adequacy', 'timeFrame': 'up to 7d after starting renal replacement therapy', 'description': 'Adequacy will be measured using urea reduction ratio for patients on intermittent hemodialysis. For continuous renal replacement therapy, we will record the maximum blood flow rate achievable. These measurements/recordings will be made on average within 1-3 days of starting therapy.'}], 'secondaryOutcomes': [{'measure': 'blood stream infection rates', 'timeFrame': 'within 30d of catheter placement', 'description': 'Patients will be followed throughout their hospitalization, which can range from a few days to several weeks. Bloodstream infections within 30d of catheter placement will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury.', 'detailedDescription': 'The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury. In particular, we will be assessing renal replacement adequacy for patients on dialysis and continuous veno-venous hemofiltration by monitoring urea reduction ratios, venous and arterial pressures. We will also be monitoring infection rates. We will compare these outcomes in patients receiving tunneled catheters and patients receiving temporary catheters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy\n\nExclusion Criteria:\n\n* End stage renal disease\n* Chronic kidney disease 5 progression to end stage renal disease\n* Outside hospital catheter placement'}, 'identificationModule': {'nctId': 'NCT02200120', 'briefTitle': 'Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury- Assessment of Dialysis Adequacy and Infection Rates', 'orgStudyIdInfo': {'id': '99904021982'}}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sushrut Waikar, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Mallika L Mendu', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sushrut S Waikar', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}