Improving Outcomes in Peritoneal Dialysis

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Disease; Peritoneal Dialysis Access

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All incident patients requiring peritoneal dialysis for end stage renal disease of all etiologies.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient less than 16 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date)	Functional (mechanical) catheter failure; Complication induced catheter failure - Infection, Hemorrhage, Dialysate Leakage & Bowel Perforation	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to catheter failure	Catheter failure time (days elapsed from insertion to failure <365 days); Catheter failure time (days elapsed from insertion to failure >365 days)	Within 1 Year
Missing Data	Missing mandatory data fields	Baseline & 1 Year
Mortality (all cause)		Within 1 Year
Co-morbid Hospitalization Events	Non-fatal medical events requiring hospitalization, excluding PD related hospitalization	Within 1 Year
Infection events not resulting in catheter failure	Exit site / tunnel infection (early): suspected or definite infection around catheter exit site requiring intervention up to 2 weeks following catheter insertion; Exit site / tunnel infection (late): suspected or definite infection around catheter exit site requiring intervention after 2 weeks following catheter insertion; Peritonitis (early): peritonitis within 2 weeks of catheter insertion; Peritonitis (late): peritonitis after 2 weeks following catheter insertion	Within 1 Year
Leak events not resulting in catheter failure	Catheter leak events (early): suspected or definite catheter site leak requiring intervention up to 2 weeks following catheter insertion; Catheter leak events (late): suspected or definite catheter site leak requiring intervention after 2 weeks following catheter insertion	Within 1 Year
Modality change	Change of modality from PD to any other form of renal replacement therapy	Within 1 Year
Catheter non-usage	Catheters inserted but not used for reasons other than failed initial therapy (e.g. Moncrieff)	Within 1 Year

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Victoria R Briggs, MBBS BMedSci, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Peritoneal Dialysis Access; Peritoneal Dialysis Catheter; Catheter Function
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: STH18109