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Trial record 1 of 1 for:    NCT04603014
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Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients (IPUF-HD)

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ClinicalTrials.gov Identifier: NCT04603014
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : December 21, 2022
Sponsor:
Collaborator:
Sequana Medical N.V.
Information provided by (Responsible Party):
Chris McIntyre, Lawson Health Research Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease on Dialysis Hemodialysis Peritoneal Dialysis Nonosmotic Sodium Storage Combination Product: Interdialytic peritoneal ultrafiltration with 10% dextrose solution Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Dextrose

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603014


Contacts
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Contact: Patricia Jarosz, MMASc 519-685-8500 ext 56550 patricia.jarosz@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Patricia Jarosz, MMASc    519.685.8500 ext 56550    Patricia.Jarosz@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Sequana Medical N.V.
Investigators
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Principal Investigator: Christopher W. McIntyre, MD, PhD Lawson Research Institute
More Information
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Publications:

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Responsible Party: Chris McIntyre, Professor of Medicine, Medical Biophysics and Pediatrics, School of Medicine and Dentistry, Western University; Director of The Kidney Clinical Research Unit, London Health Sciences Centre, London, ON, Canada, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04603014    
Other Study ID Numbers: 115423
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency