Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients
- Conditions
- Peritoneal DialysisHemodialysisEnd Stage Renal Disease on DialysisNonosmotic Sodium Storage
- Interventions
- Combination Product: Interdialytic peritoneal ultrafiltration with 10% dextrose solution
- Registration Number
- NCT04603014
- Lead Sponsor
- London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interdialytic peritoneal ultrafiltration Interdialytic peritoneal ultrafiltration with 10% dextrose solution Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
- Primary Outcome Measures
Name Time Method Skin sodium concentration End of week 4 Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.
Adverse events iPUF interventions on Week 2, 3 and 4 Completion of the iPUF treatment without adverse events
- Secondary Outcome Measures
Name Time Method Total weekly sodium removal with interdialytic peritoneal ultrafiltration week 2, 3, 4 Total weekly sodium removal with peritoneal dialysis in intervention weeks
Interdialytic weight gain 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
Home blood pressure week 1 vs week 4, week 1 vs 5-6 Changes in home blood pressure at baseline vs end of intervention and vs washout
Changes in serum sodium Through study completion, average of all study treatments Post-iPUF change in serum sodium
Total volume of fluid removed with interdialytic peritoneal ultrafiltration week 2, 3, 4 Total volume of fluid removed with peritoneal dialysis in intervention weeks
Mean intradialytic hemodynamics week 1 vs 4, week 1 vs 6 Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight
Regional wall motion abnormalities week 1 vs 4, week 1 vs 6 Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis
Symptoms week 1 vs 4, week 1 vs 6 Changes in symptoms as measured with the London Evaluation of Illness questionnaire
Infusion pain Through study completion, average of all study treatments Infusion pain as measured with 0-10 visual analog scale
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada