Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT02207751
Status:
WITHDRAWN
Last Update Posted:
2016-04-14
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Outcomes in Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-13', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-07-31', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)', 'timeFrame': '1 Year', 'description': '1. Functional (mechanical) catheter failure\n2. Complication induced catheter failure - Infection, Hemorrhage, Dialysate Leakage \\& Bowel Perforation'}], 'secondaryOutcomes': [{'measure': 'Time to catheter failure', 'timeFrame': 'Within 1 Year', 'description': '* Catheter failure time (days elapsed from insertion to failure \\<365 days)\n* Catheter failure time (days elapsed from insertion to failure \\>365 days)'}, {'measure': 'Missing Data', 'timeFrame': 'Baseline & 1 Year', 'description': 'Missing mandatory data fields'}, {'measure': 'Mortality (all cause)', 'timeFrame': 'Within 1 Year'}, {'measure': 'Co-morbid Hospitalization Events', 'timeFrame': 'Within 1 Year', 'description': 'Non-fatal medical events requiring hospitalization, excluding PD related hospitalization'}, {'measure': 'Infection events not resulting in catheter failure', 'timeFrame': 'Within 1 Year', 'description': '* Exit site / tunnel infection (early): suspected or definite infection around catheter exit site requiring intervention up to 2 weeks following catheter insertion\n* Exit site / tunnel infection (late): suspected or definite infection around catheter exit site requiring intervention after 2 weeks following catheter insertion\n* Peritonitis (early): peritonitis within 2 weeks of catheter insertion\n* Peritonitis (late): peritonitis after 2 weeks following catheter insertion'}, {'measure': 'Leak events not resulting in catheter failure', 'timeFrame': 'Within 1 Year', 'description': '* Catheter leak events (early): suspected or definite catheter site leak requiring intervention up to 2 weeks following catheter insertion\n* Catheter leak events (late): suspected or definite catheter site leak requiring intervention after 2 weeks following catheter insertion'}, {'measure': 'Modality change', 'timeFrame': 'Within 1 Year', 'description': 'Change of modality from PD to any other form of renal replacement therapy'}, {'measure': 'Catheter non-usage', 'timeFrame': 'Within 1 Year', 'description': 'Catheters inserted but not used for reasons other than failed initial therapy (e.g. Moncrieff)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Peritoneal Dialysis Access', 'Peritoneal Dialysis Catheter', 'Catheter Function'], 'conditions': ['Chronic Kidney Disease', 'Peritoneal Dialysis Access']}, 'descriptionModule': {'briefSummary': 'The objective is to understand the best way to place Peritoneal Dialysis (PD) catheters, and the best way to collect data regarding their function in England, Wales and Northern Ireland.\n\nPhase 1: We will carry out a detailed examination of existing returned pilot data with emphasis on data fields with poor data completeness and perform root cause analysis, and assess deficiencies in data field definition to identify improvements to be implemented. We will construct and disseminate electronic survey material to all study centres with targeted visits by the Principle Investigator undertaken. These visits will facilitate insight into local organization of data collection including interaction with designated individuals responsible for data returns. PD training days will be organized with emphasis on clinical practice feedback utilizing data acquired in the initial phases. Hospital Episode Statistics will be linked to existing acquired PD patient information to ensure the accuracy of collected data. An online data acquisition system will be developed to allow direct data entry from centres.\n\nPhase 2: On-going and sustained data acquisition performed on a prospective basis.\n\nPhase 3: Primary data analysis including clinical practice variation in England, Wales and Northern Ireland to identify site specific PD catheter functionality variation. Additionally, patient and site specific characteristics that predict clinical outcomes in PD will be identified and characterised.\n\nPhase 4: Clinical guidelines will be developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All incident patients requiring peritoneal dialysis for end stage renal disease of all etiologies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult (16 years or over) patient requiring first PD catheter placement\n\nExclusion Criteria:\n\n* Patient less than 16 years'}, 'identificationModule': {'nctId': 'NCT02207751', 'briefTitle': 'Improving Outcomes in Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Improving Outcomes in Peritoneal Dialysis: Identification and Characterization of Optimal Clinical Practice to Enhance Peritoneal Dialysis Catheter Functionality, Minimize Access-related Complications and Promote Peritoneal Dialysis as an Initiating Therapeutic Modality for Chronic Kidney Disease.', 'orgStudyIdInfo': {'id': 'STH18109'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Victoria R Briggs, MBBS BMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}