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Clinical Trials/NCT02207751
NCT02207751
Withdrawn
Not Applicable

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.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Primary Endpoint
Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)
Status
Withdrawn
Last Updated
10 years ago

Overview

Brief Summary

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.

Phase 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.

Phase 2: On-going and sustained data acquisition performed on a prospective basis.

Phase 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.

Phase 4: Clinical guidelines will be developed.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
August 2017
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Any adult (16 years or over) patient requiring first PD catheter placement

Exclusion Criteria

  • Patient less than 16 years

Outcomes

Primary Outcomes

Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)

Time Frame: 1 Year

1. Functional (mechanical) catheter failure 2. Complication induced catheter failure - Infection, Hemorrhage, Dialysate Leakage \& Bowel Perforation

Secondary Outcomes

  • Infection events not resulting in catheter failure(Within 1 Year)
  • Leak events not resulting in catheter failure(Within 1 Year)
  • Missing Data(Baseline & 1 Year)
  • Co-morbid Hospitalization Events(Within 1 Year)
  • Time to catheter failure(Within 1 Year)
  • Mortality (all cause)(Within 1 Year)
  • Modality change(Within 1 Year)
  • Catheter non-usage(Within 1 Year)

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