Improving Outcomes in Peritoneal Dialysis

Chronic Kidney Disease Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02207751
• Other study ID #: STH18109
• Status: Withdrawn
• Phase: N/A
• First received: July 29, 2014
• Last updated: April 13, 2016
• Start date: September 2014
• Est. completion date: August 2017

Study information

• Verified date: April 2016
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient less than 16 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Peritoneal Dialysis Access
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Baxter Healthcare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Missing Data	Missing mandatory data fields	Baseline & 1 Year	No
Secondary	Mortality (all cause)		Within 1 Year	No
Secondary	Co-morbid Hospitalization Events	Non-fatal medical events requiring hospitalization, excluding PD related hospitalization	Within 1 Year	No
Secondary	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	No
Secondary	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	No
Secondary	Modality change	Change of modality from PD to any other form of renal replacement therapy	Within 1 Year	No
Secondary	Catheter non-usage	Catheters inserted but not used for reasons other than failed initial therapy (e.g. Moncrieff)	Within 1 Year	No