10 Participants Needed

Peritoneal Ultrafiltration for Chronic Kidney Failure

(IPUF-HD Trial)

PJ
Overseen ByPatricia Jarosz, MMASc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

CW

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

I can't reach my target weight with my current treatment.
I undergo hemodialysis up to three times a week.
I need more dialysis sessions to reach my target weight.
See 3 more

Exclusion Criteria

I cannot undergo peritoneal dialysis due to health reasons.
I cannot have an MRI due to certain health reasons.
My diabetes is not well-controlled.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Assessment of residual renal function, volume, hemodynamic and cardiac status during HD

1 week

Treatment

Participants receive interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks

3 weeks
2 visits per week (in-center)

Wash-out

Monitoring of potential residual effects of the iPUF intervention

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

  • Interdialytic Peritoneal UltraFiltration
Trial OverviewThe study tests if extra peritoneal dialysis using a dextrose solution can better remove excess sodium from tissues in-between regular hemodialysis sessions. Ten patients will have this additional treatment twice weekly for three weeks and undergo leg MRIs to measure tissue sodium before and after the study.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Interdialytic peritoneal ultrafiltrationExperimental Treatment1 Intervention
Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks

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

Trials
686
Recruited
427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
668
Recruited
424,000+

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

Sequana Medical N.V.

Industry Sponsor

Trials
16
Recruited
820+

Findings from Research

Extracorporeal ultrafiltration (UF) is effective for short-term management of patients with congestive heart failure (CHF) who have severe fluid overload, leading to significant improvements in symptoms and quality of life.
Peritoneal dialysis (PD) may be more suitable for long-term treatment of CHF, but further research is needed to determine if these therapies can improve survival rates in patients with refractory CHF.
The role of peritoneal dialysis in the management of treatment-resistant congestive heart failure: A European perspective.Khalifeh, N., Vychytil, A., Hörl, WH.[2019]
In a study of nine peritoneal dialysis patients with poor ultrafiltration, using two icodextrin exchanges per day led to an average body weight reduction of 2.9 kg in six patients, indicating potential efficacy in managing fluid retention.
The treatment appeared safe, with stable HbA1c levels in diabetic patients and a slight decrease in serum sodium, suggesting that further long-term studies are needed to evaluate the overall impact and safety of this approach.
Two icodextrin exchanges per day in peritoneal dialysis patients with ultrafiltration failure: one center's experience and review of the literature.Dousdampanis, P., Trigka, K., Chu, M., et al.[2021]
A study of 1,203 patients undergoing peritoneal dialysis (PD) from 1990 to 2019 showed significant improvements in patient survival rates, with 5-year survival increasing from 64% in the 1990-1999 cohort to 93% in the 2010-2019 cohort.
The rate of peritonitis, a common complication in PD, decreased significantly over time, from 0.278 episodes per patient-year to 0.162, indicating enhanced treatment protocols and care quality in the PD center.
Evolving outcomes of peritoneal dialysis: secular trends at a single large center over three decades.Kang, M., Kim, YL., Kang, E., et al.[2021]

References

The role of peritoneal dialysis in the management of treatment-resistant congestive heart failure: A European perspective. [2019]
Two icodextrin exchanges per day in peritoneal dialysis patients with ultrafiltration failure: one center's experience and review of the literature. [2021]
Evolving outcomes of peritoneal dialysis: secular trends at a single large center over three decades. [2021]
Continuous flow peritoneal dialysis (CFPD) improves ultrafiltration in children with acute kidney injury on conventional PD using a 4.25 % dextrose solution. [2018]
Protective measures against ultrafiltration failure in peritoneal dialysis patients. [2022]
Ultrafiltration failure in peritoneal dialysis: a pathophysiologic approach. [2022]
Risk factors responsible for ultrafiltration failure in early stages of peritoneal dialysis. [2020]
Accumulation of advanced glycation end products in the peritoneal vasculature of continuous ambulatory peritoneal dialysis patients with low ultra-filtration. [2019]
What is the link between poor ultrafiltration and increased mortality in anuric patients on automated peritoneal dialysis? Analysis of data from EAPOS. [2020]
Immunopathological changes in a uraemic rat model for peritoneal dialysis. [2017]
[Complications after placement of peritoneal catheter]. [2019]