Clinical trial NCT02207751: Improving Outcomes in Peritoneal Dialysis
Official title: 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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Kidney Disease
Peritoneal Dialysis Access
Keywords: Chronic Kidney Disease
Peritoneal Dialysis Access
Peritoneal Dialysis Catheter
Catheter Function
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All incident patients requiring peritoneal dialysis for end stage renal disease of all etiologies.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patient less than 16 years

Primary outcomes:
measure: Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)
timeFrame: 1 Year
Secondary outcomes:
measure: Time to catheter failure
timeFrame: Within 1 Year
measure: Missing Data
timeFrame: Baseline & 1 Year
measure: Mortality (all cause)
timeFrame: Within 1 Year
measure: Co-morbid Hospitalization Events
timeFrame: Within 1 Year
measure: Infection events not resulting in catheter failure
timeFrame: Within 1 Year
measure: Leak events not resulting in catheter failure
timeFrame: Within 1 Year
measure: Modality change
timeFrame: Within 1 Year
measure: Catheter non-usage
timeFrame: Within 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Victoria R Briggs, MBBS BMedSci
role: PRINCIPAL_INVESTIGATOR
References: