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Improving Outcomes in Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT02207751
Recruitment Status : Withdrawn
First Posted : August 4, 2014
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.


Condition or disease
Chronic Kidney Disease Peritoneal Dialysis Access

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : September 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to catheter failure [ Time Frame: Within 1 Year ]
    • Catheter failure time (days elapsed from insertion to failure <365 days)
    • Catheter failure time (days elapsed from insertion to failure >365 days)

  2. Missing Data [ Time Frame: Baseline & 1 Year ]
    Missing mandatory data fields

  3. Mortality (all cause) [ Time Frame: Within 1 Year ]
  4. Co-morbid Hospitalization Events [ Time Frame: Within 1 Year ]
    Non-fatal medical events requiring hospitalization, excluding PD related hospitalization

  5. Infection events not resulting in catheter failure [ Time Frame: Within 1 Year ]
    • 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

  6. Leak events not resulting in catheter failure [ Time Frame: Within 1 Year ]
    • 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

  7. Modality change [ Time Frame: Within 1 Year ]
    Change of modality from PD to any other form of renal replacement therapy

  8. Catheter non-usage [ Time Frame: Within 1 Year ]
    Catheters inserted but not used for reasons other than failed initial therapy (e.g. Moncrieff)



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All incident patients requiring peritoneal dialysis for end stage renal disease of all etiologies.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient less than 16 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207751


Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Victoria R Briggs, MBBS BMedSci Sheffield Teaching Hospitals NHS Foundation Trust
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02207751    
Other Study ID Numbers: STH18109
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Chronic Kidney Disease
Peritoneal Dialysis Access
Peritoneal Dialysis Catheter
Catheter Function
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency