Peritoneal DialysisNCT05381051
Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort
An observational study of Peritoneal Dialysis, run by RenJi Hospital.
Trial summary
A fast peritoneal solute transfer rate (PSTR) has been linked to worse survival especially in continuous ambulatory peritoneal dialysis (PD) cohort. In more recent cohorts, where automated PD and icodextrin were more widely used, this association disappears. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Dialysis
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Both gender, end stage renal disease on PD treatment
Who may be able to join
- Patients are Han Chinese;
- Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization;
- Patients successfully complete the first peritoneal equilibration test(PET);
- Follow up regularly in our PD center.
Who cannot join
- Patients from hemodialysis to peritoneal dialysis;
- Patients who need peritoneal dialysis due to transplant-renal loss;
About this study
A fast peritoneal solute transfer rate (PSTR) has been linked to worse survival especially in continuous ambulatory peritoneal dialysis (PD) cohort. In more recent cohorts, where automated PD and icodextrin were more widely used, this association disappears. The current study intended to clarify whether fast PSTR is related to worse outcome in this single center cohort with minimal use of APD and no icodextrin and otherwise modern management practice. Our study found that baseline PSTR predicted patient outcome in univariate survival analysis but not in multivariate analysis. The relationship between comorbidity and faster baseline PSTR may partly explain it.
- Conditions
- Peritoneal Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| original cohort | In the original cohort, 314 patients had catheter implantation between 1st Jan, 2005 to 31st Dec 2009. 269 patients started PD and followed up in our center. 26 patients were excluded due to missing baseline peritoneal membrane function data. 243 patients (n=243, age 53.2±16.3 year) entered the analysis. | |
| validation cohort | The validation cohort started PD from 2015 to 2018. It was originally designed for a 12 month observational study around fluid balance. 187 patients were in the validation cohort (age 53.0±15.9 year). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between fast PSTR and worse outcome in PD.
Baseline PSTR predicted patient outcome in univariate survival analysis but not in multivariate analysis. The relationship between comorbidity and faster baseline PSTR may partly explain it.
Measured: The data collection time period of the study is over 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Retrospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381051
- Sponsor's protocol ID
- 2016[099]K
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort
- ClinicalTrials.gov ID
- NCT05381051
- Acronym / sponsor ID
- 2016[099]K
- Conditions
- Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 May 2022 (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.
A fast peritoneal solute transfer rate (PSTR) has been linked to worse survival especially in continuous ambulatory peritoneal dialysis (PD) cohort. In more recent cohorts, where automated PD and icodextrin were more widely used, this association disappears. The current study intended to clarify whether fast PSTR is related to worse outcome in this single center cohort with minimal use of APD and no icodextrin and otherwise modern management practice. Our study found that baseline PSTR predicted patient outcome in univariate survival analysis but not in multivariate analysis. The relationship between comorbidity and faster baseline PSTR may partly explain it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| original cohort | – | –In the original cohort, 314 patients had catheter implantation between 1st Jan, 2005 to 31st Dec 2009. 269 patients started PD and followed up in our center. 26 patients were excluded due to missing baseline peritoneal membrane function data. 243 patients (n=243, age 53.2±16.3 year) entered the analysis. |
| validation cohort | – | –The validation cohort started PD from 2015 to 2018. It was originally designed for a 12 month observational study around fluid balance. 187 patients were in the validation cohort (age 53.0±15.9 year). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both gender, end stage renal disease on PD treatment
Key inclusion criteria (4 listed)
- Patients are Han Chinese;
- Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization;
- Patients successfully complete the first peritoneal equilibration test(PET);
- Follow up regularly in our PD center.
Key exclusion criteria (2 listed)
- Patients from hemodialysis to peritoneal dialysis;
- Patients who need peritoneal dialysis due to transplant-renal loss;
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
The relationship between fast PSTR and worse outcome in PD.
Time frame: The data collection time period of the study is over 10 years.
Baseline PSTR predicted patient outcome in univariate survival analysis but not in multivariate analysis. The relationship between comorbidity and faster baseline PSTR may partly explain it.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis, run by RenJi Hospital.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 19 May 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The relationship between fast PSTR and worse outcome in PD. (time frame: The data collection time period of the study is over 10 years.). 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 19 May 2022.