Chronic Kidney DiseaseNCT02207751
Improving Outcomes in Peritoneal Dialysis
An observational study of Chronic Kidney Disease and Peritoneal Dialysis Access, run by Sheffield Teaching Hospitals NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Kidney Disease, Peritoneal Dialysis Access
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All incident patients requiring peritoneal dialysis for end stage renal disease of all etiologies.
Who may be able to join
- Any adult (16 years or over) patient requiring first PD catheter placement
Who cannot join
- Patient less than 16 years
About this study
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.
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.
Read more
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.
- Conditions
- Chronic Kidney Disease, Peritoneal Dialysis Access
- Keywords
- Chronic Kidney Disease, Peritoneal Dialysis Access, Peritoneal Dialysis Catheter, Catheter Function
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Year
Secondary outcomes (8)
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)
Measured: Within 1 Year
Missing Data
Missing mandatory data fields
Measured: Baseline & 1 Year
Mortality (all cause)
Measured: Within 1 Year
Co-morbid Hospitalization Events
Non-fatal medical events requiring hospitalization, excluding PD related hospitalization
Measured: 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
Measured: 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
Measured: Within 1 Year
Modality change
Change of modality from PD to any other form of renal replacement therapy
Measured: Within 1 Year
Catheter non-usage
Catheters inserted but not used for reasons other than failed initial therapy (e.g. Moncrieff)
Measured: Within 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Victoria R Briggs, MBBS BMedSci, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207751
- Sponsor's protocol ID
- STH18109
- Status last verified
- Apr 2016
- First submitted
- 29 Jul 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02207751
- Acronym / sponsor ID
- STH18109
- Conditions
- Chronic Kidney Disease, Peritoneal Dialysis Access
- Keywords
- Chronic Kidney Disease, Peritoneal Dialysis Access, Peritoneal Dialysis Catheter, Catheter Function
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All incident patients requiring peritoneal dialysis for end stage renal disease of all etiologies.
Key inclusion criteria (1 listed)
- Any adult (16 years or over) patient requiring first PD catheter placement
Key exclusion criteria (1 listed)
- Patient less than 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Time to catheter failure
Time frame: Within 1 Year
Missing Data
Time frame: Baseline & 1 Year
Mortality (all cause)
Time frame: Within 1 Year
Co-morbid Hospitalization Events
Time frame: Within 1 Year
Infection events not resulting in catheter failure
Time frame: Within 1 Year
Leak events not resulting in catheter failure
Time frame: Within 1 Year
Modality change
Time frame: Within 1 Year
Catheter non-usage
Time frame: Within 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria R Briggs, MBBS BMedSci principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Peritoneal Dialysis Access, run by Sheffield Teaching Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal dialysis catheter "survival" (sustained function) at 365 days post-insertion (insertion date) (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.