Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Combination Product: Interdialytic peritoneal ultrafiltration with 10% dextrose solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interdialytic peritoneal ultrafiltration<br>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<br>* Interdialytic peritoneal ultrafiltration with incremental doses of a 10% dextrose solution, after hemodialysis twice weekly for three consecutive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin sodium concentration | 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 | 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 | 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 | Total weekly sodium removal with peritoneal dialysis in intervention weeks | week 2, 3, 4 | 
| Total volume of fluid removed with interdialytic peritoneal ultrafiltration | Total volume of fluid removed with peritoneal dialysis in intervention weeks | week 2, 3, 4 | 
| Home blood pressure | 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 | 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 | Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis | week 1 vs 4, week 1 vs 6 | 
| Symptoms | Changes in symptoms as measured with the London Evaluation of Illness questionnaire | week 1 vs 4, week 1 vs 6 | 
| Infusion pain | Infusion pain as measured with 0-10 visual analog scale | Through study completion, average of all study treatments | 
| Changes in serum sodium | Post-iPUF change in serum sodium | Through study completion, average of all study treatments |