A Phase 2 interventional study of Interdialytic peritoneal ultrafiltration with 10% dextrose solution in End Stage Renal Disease on Dialysis, Hemodialysis and Peritoneal Dialysis, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 2, Interventional, and Treatment
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.
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.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least one of the following:
Exclusion Criteria
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
Skin sodium concentration
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
Adverse events
Completion of the iPUF treatment without adverse events
Time frame: iPUF interventions on Week 2, 3 and 4
Interdialytic weight gain
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
Total weekly sodium removal with interdialytic peritoneal ultrafiltration
Total weekly sodium removal with peritoneal dialysis in intervention weeks
Time frame: week 2, 3, 4
Total volume of fluid removed with interdialytic peritoneal ultrafiltration
Total volume of fluid removed with peritoneal dialysis in intervention weeks
Time frame: week 2, 3, 4
Home blood pressure
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
Mean intradialytic hemodynamics
Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight
Time frame: week 1 vs 4, week 1 vs 6
Regional wall motion abnormalities
Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis
Time frame: week 1 vs 4, week 1 vs 6
Symptoms
Changes in symptoms as measured with the London Evaluation of Illness questionnaire
Time frame: week 1 vs 4, week 1 vs 6
Infusion pain
Infusion pain as measured with 0-10 visual analog scale
Time frame: Through study completion, average of all study treatments
Changes in serum sodium
Post-iPUF change in serum sodium
Time frame: Through study completion, average of all study treatments
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's