Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort

May 18, 2022 updated by: RenJi Hospital
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both gender, end stage renal disease on PD treatment

Description

Inclusion Criteria:

  1. Patients are Han Chinese;
  2. Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization;
  3. Patients successfully complete the first peritoneal equilibration test(PET);
  4. Follow up regularly in our PD center.

Exclusion Criteria:

  1. Patients from hemodialysis to peritoneal dialysis;
  2. Patients who need peritoneal dialysis due to transplant-renal loss;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The data collection time period of the study is over 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2016[099]K

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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