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Clinical Trials in Canada / NCT04603014
Active, not recruiting Phase 2

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

NCT04603014 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2021-01-01
Last updated
2026-05-04

Condition(s) studied

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)

Trial sites (1)

FacilityCityRegionStatus
London Health Sciences Centre London Ontario

More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada

Other trials for the same condition

Official registry record

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.

View NCT04603014 on ClinicalTrials.gov ↗ ← All trials in Canada