Removing excess sodium in hemodialysis patients using peritoneal dialysis
Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients
This study is testing if a new method using peritoneal dialysis can help people on hemodialysis get rid of extra sodium and improve their health between treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04603014 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the feasibility and effectiveness of interdialytic peritoneal ultrafiltration (iPUF) in chronic hemodialysis patients. Participants will undergo the surgical insertion of a Tenckhoff peritoneal dialysis catheter and receive a 10% dextrose solution for sodium removal between hemodialysis sessions. The study will monitor sodium levels using magnetic resonance imaging and assess patient safety through symptom tracking and blood pressure monitoring. The intervention aims to improve volume management and sodium removal in patients struggling with excess sodium retention.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with significant interdialytic weight gain or difficulty achieving dry weight on their current hemodialysis regimen.
Not a fit: Patients with contraindications to peritoneal dialysis or those with uncontrolled diabetes or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance sodium removal and improve overall health outcomes for patients on hemodialysis.
How similar studies have performed: While this approach is novel, similar studies exploring sodium removal techniques in dialysis patients have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Christopher W. McIntyre, MD, PhD — Lawson Research Institute
- Study coordinator: Patricia Jarosz, MMASc
- Email: patricia.jarosz@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.