Peritoneal Dialysis Access FailureNCT04034628
Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion
An observational study of Peritoneal Dialysis Access Failure and Peritoneal Dialysis Complication, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Peritoneal dialysis (PD) is actively promoted as the preferred form of dialysis for patients with kidney failure. However, 1 in 5 patients will experience a signification catheter insertion-related PD catheter complication in the first 6 months following insertion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Access Failure, Peritoneal Dialysis Complication
- What is being tested?
- Peritoneal Catheter Insertion - Laparoscopic and Peritoneal Catheter Insertion - Percutaneous
- Type of treatment
- Medical device
- How many people
- 2,320 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 30 Mar 2024
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will identify all patients undergoing their first PD catheter insertion during the study period, at 20 participating centers in Canada and the USA (see Appendix 1). A total of 800 cases have been captured to date during our pilot study and an additional 1,520 cases will be accrued over a 30-month period, for a total sample size of 2,320 PD catheter insertions. We will attempt to collect information about consecutive patients undergoing PD catheter attempts/insertions in order to accurately measure local performance. However if a waiver of consent cannot be obtained at participating centers, then non-consecutive patients will be enrolled
Inclusion Criteria:patients must be 18 years of age or older; have advanced chronic kidney disease; have chosen PD as their intended treatment modality; and undergone their first PD catheter placement during the study period.
Exclusion Criteria:patients who intend to transfer to another PD program or who are scheduled to receive a transplant within 3 months of the start of PD therapy will be excluded
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N1A4
Matthew Oliver, MD MHS, 416-480-4755, matthew.oliver@sunnybrook.ca
MD PhD
About this study
Peritoneal dialysis (PD) is actively promoted as the preferred form of dialysis for patients with kidney failure. However, 1 in 5 patients will experience a signification catheter insertion-related PD catheter complication in the first 6 months following insertion. Little is known about the patient-, operator-, and center-level factors that influence PD catheter complications. There is a need to identify key modifiable practices to focus randomized trials and quality improvement efforts. We will leverage prior funding, a custom-built data collection platform, pilot data, and a group of engaged stakeholders, partners, and knowledge users to: a) Determine if method of insertion is associated with PD catheter complications b) Identify operator/center characteristics and practices associated with PD catheter complications c) Use a data-driven approach to achieve expert consensus on optimal practices for PD catheter insertion and care.
Read the detailed description
Patient population and setting. We will identify all patients undergoing their first PD catheter insertion during the study period, at 20 participating centers in Canada and the USA (see Appendix 1). A total of 800 cases have been captured to date during our pilot study and an additional 1,520 cases will be accrued over a 30-month period, for a total sample size of 2,320 PD catheter insertions. We will attempt to collect information about consecutive patients undergoing PD catheter attempts/insertions in order to accurately measure local performance. However if a waiver of consent cannot be obtained at participating centers, then non-consecutive patients will be enrolled.
Inclusion criteria: patients must be 18 years of age or older; have advanced chronic kidney disease; have chosen PD as their intended treatment modality; and undergone their first PD catheter placement during the study period.
Exclusion criteria: patients who intend to transfer to another PD program or who are scheduled to receive a transplant within 3 months of the start of PD therapy will be excluded. Data source: ISPD Catheter Registry. The ISPD Catheter Registry is a web-based data collection tool that was custom-built for this project. It was developed based on a patented approach (Canadian patent #2,666,569; issued 2/28/2017)
Patient-level variables for our models will include baseline demographic (age, sex), comorbidity [body mass index (BMI), chronic kidney disease (dialysis-dependent vs. not), diabetes mellitus, cardiovascular disease (coronary artery disease, peripheral vascular disease, cerebrovascular disease), congestive heart failure, respiratory disease, liver disease, abdominal scarring, history of abdominal hernias], laboratory (hemoglobin, albumin), and medication variables (use of anticoagulants, antiplatelet, immunosuppressive medications).
Operator variables include operator volume, advanced training in PD catheter insertion and years of experience placing PD catheters.
Primary outcome: PD catheter complications. Our primary outcome will be the composite of the need for interventional procedures, emergency room visits and hospitalizations, reduction in time on PD, or discontinuation of PD therapy due to insertion-related PD catheter complications.
Sample size of 2,000 patients will provide 80% power to detect a 25% relative reduction in the risk of our primary outcome in those undergoing laparoscopic insertion of their catheter, across a range of possible ICC values. In order to guard against a larger than anticipated intra-class correlation coefficient(up to 0.001), we will target a sample size of 2,320 patients
- Being tested
- Peritoneal Catheter Insertion - Laparoscopic, Peritoneal Catheter Insertion - Percutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal Catheter Insertion - LaparoscopicDevice
Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
Peritoneal Catheter Insertion - PercutaneousDevice
Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic insertion | Individuals who undergo laparoscopic PD catheter insertion Receives: Device: Peritoneal Catheter Insertion - Laparoscopic; Device: Peritoneal Catheter Insertion - Percutaneous | |
| Percutaneous insertion | Individuals who undergo percutaneous PD catheter insertion by either a nephrologist or radiologist. Receives: Device: Peritoneal Catheter Insertion - Laparoscopic; Device: Peritoneal Catheter Insertion - Percutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion related complications
Complications (exit site leak, flow restriction, pain, infection, bleeding) likely associated with the method of insertion
Measured: 1 year following the start of PD therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis Access FailureStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- 2,320 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Oliver, Sunnybrook Health Sciences Centre
- Investigators
- Matthew Oliver, MD MHS, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034628
- Sponsor's protocol ID
- 160-2019
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We would be willing to collaborate depending on the project.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion
- ClinicalTrials.gov ID
- NCT04034628
- Acronym / sponsor ID
- 160-2019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,320 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 26 Jul 2019 (actual)
- 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.
Peritoneal dialysis (PD) is actively promoted as the preferred form of dialysis for patients with kidney failure. However, 1 in 5 patients will experience a signification catheter insertion-related PD catheter complication in the first 6 months following insertion. Little is known about the patient-, operator-, and center-level factors that influence PD catheter complications. There is a need to identify key modifiable practices to focus randomized trials and quality improvement efforts. We will leverage prior funding, a custom-built data collection platform, pilot data, and a group of engaged stakeholders, partners, and knowledge users to: a) Determine if method of insertion is associated with PD catheter complications b) Identify operator/center characteristics and practices associated with PD catheter complications c) Use a data-driven approach to achieve expert consensus on optimal practices for PD catheter insertion and care.
Detailed description
Patient population and setting. We will identify all patients undergoing their first PD catheter insertion during the study period, at 20 participating centers in Canada and the USA (see Appendix 1). A total of 800 cases have been captured to date during our pilot study and an additional 1,520 cases will be accrued over a 30-month period, for a total sample size of 2,320 PD catheter insertions. We will attempt to collect information about consecutive patients undergoing PD catheter attempts/insertions in order to accurately measure local performance. However if a waiver of consent cannot be obtained at participating centers, then non-consecutive patients will be enrolled.
Inclusion criteria: patients must be 18 years of age or older; have advanced chronic kidney disease; have chosen PD as their intended treatment modality; and undergone their first PD catheter placement during the study period.
Exclusion criteria: patients who intend to transfer to another PD program or who are scheduled to receive a transplant within 3 months of the start of PD therapy will be excluded. Data source: ISPD Catheter Registry. The ISPD Catheter Registry is a web-based data collection tool that was custom-built for this project. It was developed based on a patented approach (Canadian patent #2,666,569; issued 2/28/2017)
Patient-level variables for our models will include baseline demographic (age, sex), comorbidity [body mass index (BMI), chronic kidney disease (dialysis-dependent vs. not), diabetes mellitus, cardiovascular disease (coronary artery disease, peripheral vascular disease, cerebrovascular disease), congestive heart failure, respiratory disease, liver disease, abdominal scarring, history of abdominal hernias], laboratory (hemoglobin, albumin), and medication variables (use of anticoagulants, antiplatelet, immunosuppressive medications).
Operator variables include operator volume, advanced training in PD catheter insertion and years of experience placing PD catheters.
Primary outcome: PD catheter complications. Our primary outcome will be the composite of the need for interventional procedures, emergency room visits and hospitalizations, reduction in time on PD, or discontinuation of PD therapy due to insertion-related PD catheter complications.
Sample size of 2,000 patients will provide 80% power to detect a 25% relative reduction in the risk of our primary outcome in those undergoing laparoscopic insertion of their catheter, across a range of possible ICC values. In order to guard against a larger than anticipated intra-class correlation coefficient(up to 0.001), we will target a sample size of 2,320 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic insertion | – | Device: Peritoneal Catheter Insertion - Laparoscopic, Device: Peritoneal Catheter Insertion - PercutaneousIndividuals who undergo laparoscopic PD catheter insertion |
| Percutaneous insertion | – | Device: Peritoneal Catheter Insertion - Laparoscopic, Device: Peritoneal Catheter Insertion - PercutaneousIndividuals who undergo percutaneous PD catheter insertion by either a nephrologist or radiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will identify all patients undergoing their first PD catheter insertion during the study period, at 20 participating centers in Canada and the USA (see Appendix 1). A total of 800 cases have been captured to date during our pilot study and an additional 1,520 cases will be accrued over a 30-month period, for a total sample size of 2,320 PD catheter insertions. We will attempt to collect information about consecutive patients undergoing PD catheter attempts/insertions in order to accurately measure local performance. However if a waiver of consent cannot be obtained at participating centers, then non-consecutive patients will be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal Catheter Insertion - LaparoscopicInsertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure | Device | Laparoscopic insertion, Percutaneous insertion |
| Peritoneal Catheter Insertion - PercutaneousInsertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure | Device | Laparoscopic insertion, Percutaneous insertion |
Primary outcome
Insertion related complications
Time frame: 1 year following the start of PD therapy
Complications (exit site leak, flow restriction, pain, infection, bleeding) likely associated with the method of insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: Undecided. We would be willing to collaborate depending on the project.
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.
Matthew Oliver, MD MHS principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis Access Failure and Peritoneal Dialysis Complication, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Oliver, MD MHS (416-480-4755, matthew.oliver@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion related complications (time frame: 1 year following the start of PD therapy). 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 26 Jul 2019.