Clinical trial NCT04603014: Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients
Official title: Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: End Stage Renal Disease on Dialysis
Hemodialysis
Peritoneal Dialysis
Nonosmotic Sodium Storage
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Sequana Medical N.V.
First posted: 2020-10-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Skin sodium concentration
timeFrame: End of week 4
measure: Adverse events
timeFrame: iPUF interventions on Week 2, 3 and 4
Secondary outcomes:
measure: Interdialytic weight gain
timeFrame: week 1 vs 4, week 1 vs 5-6
measure: Total weekly sodium removal with interdialytic peritoneal ultrafiltration
timeFrame: week 2, 3, 4
measure: Total volume of fluid removed with interdialytic peritoneal ultrafiltration
timeFrame: week 2, 3, 4
measure: Home blood pressure
timeFrame: week 1 vs week 4, week 1 vs 5-6
measure: Mean intradialytic hemodynamics
timeFrame: week 1 vs 4, week 1 vs 6
measure: Regional wall motion abnormalities
timeFrame: week 1 vs 4, week 1 vs 6
measure: Symptoms
timeFrame: week 1 vs 4, week 1 vs 6
measure: Infusion pain
timeFrame: Through study completion, average of all study treatments
measure: Changes in serum sodium
timeFrame: Through study completion, average of all study treatments
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Lawson Research Institute
name: Christopher W. McIntyre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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