Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients (IPUF-HD)
Primary Purpose
End Stage Renal Disease on Dialysis, Hemodialysis, Peritoneal Dialysis
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Interdialytic peritoneal ultrafiltration with 10% dextrose solution
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease on Dialysis
Eligibility 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
Sites / Locations
- London Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interdialytic peritoneal ultrafiltration
Arm Description
Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
Outcomes
Primary Outcome Measures
Skin sodium concentration
Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.
Adverse events
Completion of the iPUF treatment without adverse events
Secondary Outcome Measures
Interdialytic weight gain
Difference in interdialytic weight gain at run-in week vs end of intervention, vs wash-out
Total weekly sodium removal with interdialytic peritoneal ultrafiltration
Total weekly sodium removal with peritoneal dialysis in intervention weeks
Total volume of fluid removed with interdialytic peritoneal ultrafiltration
Total volume of fluid removed with peritoneal dialysis in intervention weeks
Home blood pressure
Changes in home blood pressure at baseline vs end of intervention and vs washout
Mean intradialytic hemodynamics
Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight
Regional wall motion abnormalities
Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis
Symptoms
Changes in symptoms as measured with the London Evaluation of Illness questionnaire
Infusion pain
Infusion pain as measured with 0-10 visual analog scale
Changes in serum sodium
Post-iPUF change in serum sodium
Full Information
NCT ID
NCT04603014
First Posted
October 13, 2020
Last Updated
August 30, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Sequana Medical N.V.
1. Study Identification
Unique Protocol Identification Number
NCT04603014
Brief Title
Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients
Acronym
IPUF-HD
Official Title
Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Sequana Medical N.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis, Hemodialysis, Peritoneal Dialysis, Nonosmotic Sodium Storage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interdialytic peritoneal ultrafiltration
Arm Type
Experimental
Arm Description
Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
Intervention Type
Combination Product
Intervention Name(s)
Interdialytic peritoneal ultrafiltration with 10% dextrose solution
Intervention Description
Interdialytic peritoneal ultrafiltration with incremental doses of a 10% dextrose solution, after hemodialysis twice weekly for three consecutive weeks
Primary Outcome Measure Information:
Title
Skin sodium concentration
Description
Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.
Time Frame
End of week 4
Title
Adverse events
Description
Completion of the iPUF treatment without adverse events
Time Frame
iPUF interventions on Week 2, 3 and 4
Secondary Outcome Measure Information:
Title
Interdialytic weight gain
Description
Difference in interdialytic weight gain at run-in week vs end of intervention, vs wash-out
Time Frame
week 1 vs 4, week 1 vs 5-6
Title
Total weekly sodium removal with interdialytic peritoneal ultrafiltration
Description
Total weekly sodium removal with peritoneal dialysis in intervention weeks
Time Frame
week 2, 3, 4
Title
Total volume of fluid removed with interdialytic peritoneal ultrafiltration
Description
Total volume of fluid removed with peritoneal dialysis in intervention weeks
Time Frame
week 2, 3, 4
Title
Home blood pressure
Description
Changes in home blood pressure at baseline vs end of intervention and vs washout
Time Frame
week 1 vs week 4, week 1 vs 5-6
Title
Mean intradialytic hemodynamics
Description
Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight
Time Frame
week 1 vs 4, week 1 vs 6
Title
Regional wall motion abnormalities
Description
Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis
Time Frame
week 1 vs 4, week 1 vs 6
Title
Symptoms
Description
Changes in symptoms as measured with the London Evaluation of Illness questionnaire
Time Frame
week 1 vs 4, week 1 vs 6
Title
Infusion pain
Description
Infusion pain as measured with 0-10 visual analog scale
Time Frame
Through study completion, average of all study treatments
Title
Changes in serum sodium
Description
Post-iPUF change in serum sodium
Time Frame
Through study completion, average of all study treatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Jarosz, MMASc
Phone
519-685-8500
Ext
56550
Email
patricia.jarosz@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher W. McIntyre, MD, PhD
Organizational Affiliation
Lawson Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Jarosz, MMASc
Phone
519.685.8500
Ext
56550
Email
Patricia.Jarosz@lhsc.on.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients
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