Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients (IPUF-HD)

April 28, 2026 updated by: Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients

Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: Interdialytic peritoneal ultrafiltration (iPUF) via Tenckhoff peritoneal dialysis catheter using 10% Dextrose infusate is feasible and provides effective volume management and sodium removal in prevalent HD patients.

Overview: This is a prospective, interventional pilot study from the London Health Sciences Centre (LHSC) prevalent HD population. Study patients will undergo the surgical implantation of a Tenckhoff peritoneal dialysis catheter before study start. After the successful insertion of the Tenckhoff catheter, study patients will enter a run-in phase, where their residual renal function, volume, hemodynamic and cardiac status during HD will be assessed. During the following weeks (intervention weeks 1, 2, 3), study patients will receive in-center iPUF intervention, consisting of peritoneal infusate instillation of a 10% dextrose solution via a Tenckhoff catheter, immediately after the first two HD sessions of the week (Monday, Wednesday); the infusate will be dwelling in the study patient's peritoneal cavity for 2 hours, at the end of which the solution will be drained and the patient sent home. Study patients will be monitored during infusate administration and for the first four hours thereafter. The study intervention will be discontinued at the beginning of week 5 (Wash-out); during week 5 and the first HD session of week 6, study patients will be monitored to observe potential residual effects of the iPUF intervention.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • At least one of the following:

    • Average per-session interdialytic weight gain ≥ 4.0 % of their dry weight in the last month;
    • Inability to consistently achieve dry weight with the current treatment schedule;
    • Need for additional HD treatments to achieve prescribed dry weight.
  • Weekly HD sessions - up to three times/week
  • Age ≥18 years
  • Willing and able to give informed consent

Exclusion Criteria

  • Contraindications to peritoneal dialysis
  • Contraindications to MRI
  • Uncontrolled diabetes mellitus
  • Active infections
  • Non-compliance to hemodialysis prescription
  • Pre-study serum sodium < 130 mmol/L

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interdialytic peritoneal ultrafiltration
Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
Combination product: Interdialytic peritoneal ultrafiltration with 10% dextrose solution
Interdialytic peritoneal ultrafiltration with incremental doses of a 10% dextrose solution, after hemodialysis twice weekly for three consecutive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin sodium concentration
Time Frame: End of week 4
Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.
End of week 4
Adverse events
Time Frame: iPUF interventions on Week 2, 3 and 4
Completion of the iPUF treatment without adverse events
iPUF interventions on Week 2, 3 and 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interdialytic weight gain
Time Frame: week 1 vs 4, week 1 vs 5-6
Difference in interdialytic weight gain at run-in week vs end of intervention, vs wash-out
week 1 vs 4, week 1 vs 5-6
Total weekly sodium removal with interdialytic peritoneal ultrafiltration
Time Frame: week 2, 3, 4
Total weekly sodium removal with peritoneal dialysis in intervention weeks
week 2, 3, 4
Total volume of fluid removed with interdialytic peritoneal ultrafiltration
Time Frame: week 2, 3, 4
Total volume of fluid removed with peritoneal dialysis in intervention weeks
week 2, 3, 4
Home blood pressure
Time Frame: week 1 vs week 4, week 1 vs 5-6
Changes in home blood pressure at baseline vs end of intervention and vs washout
week 1 vs week 4, week 1 vs 5-6
Mean intradialytic hemodynamics
Time Frame: week 1 vs 4, week 1 vs 6
Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight
week 1 vs 4, week 1 vs 6
Regional wall motion abnormalities
Time Frame: week 1 vs 4, week 1 vs 6
Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis
week 1 vs 4, week 1 vs 6
Symptoms
Time Frame: week 1 vs 4, week 1 vs 6
Changes in symptoms as measured with the London Evaluation of Illness questionnaire
week 1 vs 4, week 1 vs 6
Infusion pain
Time Frame: Through study completion, average of all study treatments
Infusion pain as measured with 0-10 visual analog scale
Through study completion, average of all study treatments
Changes in serum sodium
Time Frame: Through study completion, average of all study treatments
Post-iPUF change in serum sodium
Through study completion, average of all study treatments

Collaborators and Investigators

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

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborators

Sequana Medical N.V.

Investigators

  • Principal Investigator: Christopher W. McIntyre, MD, PhD, Lawson Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2021

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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