Peritoneal Ultrafiltration for Chronic Kidney Failure
(IPUF-HD Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Interdialytic Peritoneal UltraFiltration for chronic kidney failure?
Research shows that peritoneal dialysis, a similar treatment, can effectively manage fluid overload in patients with treatment-resistant congestive heart failure, improving their quality of life and reducing hospitalizations. This suggests that Interdialytic Peritoneal UltraFiltration might also help manage fluid balance in chronic kidney failure.12345
Is peritoneal ultrafiltration safe for humans?
The research indicates that ultrafiltration failure is a significant complication in peritoneal dialysis, which can lead to serious issues like increased mortality and the need to switch to other treatments. However, these studies focus on complications rather than direct safety concerns, so it's important to consult with a healthcare provider for personalized advice.26789
How is peritoneal ultrafiltration different from other treatments for chronic kidney failure?
Peritoneal ultrafiltration is unique because it uses the peritoneum (a membrane in the abdomen) to remove excess fluid and waste from the body through osmosis and diffusion, unlike hemodialysis which filters blood outside the body. This method can be used at home and is less invasive than a kidney transplant.2561011
Research Team
Christopher W. McIntyre, MD, PhD
Principal Investigator
Lawson Research Institute
Eligibility Criteria
This trial is for adults over 18 who are on hemodialysis up to three times a week for chronic kidney failure but can't reach their prescribed dry weight. They should gain at least 4% of their dry weight between sessions and be able to consent. It's not for those with conditions that rule out peritoneal dialysis or MRI, uncontrolled diabetes, active infections, non-compliance with hemodialysis, or very low sodium levels.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Assessment of residual renal function, volume, hemodynamic and cardiac status during HD
Treatment
Participants receive interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
Wash-out
Monitoring of potential residual effects of the iPUF intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Interdialytic Peritoneal UltraFiltration
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor
Sequana Medical N.V.
Industry Sponsor