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NCT Number: NCT04603014

Interdialytic Peritoneal UltraFiltration 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

End Stage Renal Disease on Dialysis Hemodialysis Nonosmotic Sodium Storage Peritoneal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interdialytic peritoneal ultrafiltration with 10% dextrose solution

Combination Product

Interdialytic peritoneal ultrafiltration with incremental doses of a 10% dextrose solution, after hemodialysis twice weekly for three consecutive weeks

Primary outcomes

  1. 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.

  2. Adverse events

    Time frame: iPUF interventions on Week 2, 3 and 4

    Completion of the iPUF treatment without adverse events

Secondary outcomes

  1. 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

  2. Total weekly sodium removal with interdialytic peritoneal ultrafiltration

    Time frame: week 2, 3, 4

    Total weekly sodium removal with peritoneal dialysis in intervention weeks

  3. 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

  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

  5. 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

  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

  7. Symptoms

    Time frame: week 1 vs 4, week 1 vs 6

    Changes in symptoms as measured with the London Evaluation of Illness questionnaire

  8. Infusion pain

    Time frame: Through study completion, average of all study treatments

    Infusion pain as measured with 0-10 visual analog scale

  9. Changes in serum sodium

    Time frame: Through study completion, average of all study treatments

    Post-iPUF change in serum sodium

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Sequana Medical N.V.

Registry information

Official study title

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

Acronym: IPUF-HD

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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