End Stage Renal Disease on DialysisHemodialysisPeritoneal DialysisNonosmotic Sodium Storage
Investigational drug(s) / intervention(s)
Interdialytic peritoneal ultrafiltration with 10% dextrose solution
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
London Health Sciences Centre
London
Ontario
More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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