UK PDOPPS
Research type
Research Study
Full title
UK Peritoneal Dialysis Outcomes and Practice Patterns Study(UK PDOPPS)
IRAS ID
136525
Contact name
Tracy Nevatte
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
R01 DK 099165, National Institutes of Health
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
International PDOPPS is a prospective, observational cohort study of Peritoneal Dialysis (PD) patients and facilities in several countries. The aim is to advance understanding of optimal practices for PD worldwide and increase the appropriate use of PD, extend technique survival, reduce mortality and improve quality of life for patients.
Part 1 (UK Catheter study)will recruit patients who are having their first attempt at PD access with the objective of exploring the best way of placing PD access. It will involve 45 facilities in the UK. Centers will be included based on the ability to recruit a minimum of 15 patients over an 18 month period.
Part 2 ( UK component of international PDOPPS) includes centres treating more than 15 PD patients which will be randomly selected in each participating country (facilities will be stratified by characteristics such as geographic region and unit type).
Centers will complete a census and from this random samples will be taken – a prevalent PD sample and an incident PD sample.
Detailed information on the selected patients, facility protocol and physician practices will then be collected through questionnaires – the study will last a total of 3 years.
Data will be analysed at subject and center levels in order to provide the opportunity to monitor practice and policy changes and their effects on clinical outcomes i.e. time on PD therapy, mortality, hospitalisation and quality of life.
Part 2 includes the Biological Determinants of Peritoneal Dialysis (Bio-PD) ancillary study) in which patients will be asked for their consent for biological sampling including genetic analysis, and results of tests of peritoneal membrane function.
REC name
London - City & East Research Ethics Committee
REC reference
13/LO/1943
Date of REC Opinion
28 Dec 2013
REC opinion
Favourable Opinion