Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • End Stage Renal Disease on Dialysis
  • Hemodialysis
  • Nonosmotic Sodium Storage
  • Peritoneal Dialysis
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Hypothesis: Interdialytic peritoneal ultrafiltration (iPUF) via Tenckhoff peritoneal dialysis catheter using 10% Dextrose infusate is feasible and provides effective volume management and sodium removal in prevalent HD patients. Overview: This is a prospective, interventional pilot study from the Lo...

Hypothesis: Interdialytic peritoneal ultrafiltration (iPUF) via Tenckhoff peritoneal dialysis catheter using 10% Dextrose infusate is feasible and provides effective volume management and sodium removal in prevalent HD patients. Overview: This is a prospective, interventional pilot study from the London Health Sciences Centre (LHSC) prevalent HD population. Study patients will undergo the surgical implantation of a Tenckhoff peritoneal dialysis catheter before study start. After the successful insertion of the Tenckhoff catheter, study patients will enter a run-in phase, where their residual renal function, volume, hemodynamic and cardiac status during HD will be assessed. During the following weeks (intervention weeks 1, 2, 3), study patients will receive in-center iPUF intervention, consisting of peritoneal infusate instillation of a 10% dextrose solution via a Tenckhoff catheter, immediately after the first two HD sessions of the week (Monday, Wednesday); the infusate will be dwelling in the study patient's peritoneal cavity for 2 hours, at the end of which the solution will be drained and the patient sent home. Study patients will be monitored during infusate administration and for the first four hours thereafter. The study intervention will be discontinued at the beginning of week 5 (Wash-out); during week 5 and the first HD session of week 6, study patients will be monitored to observe potential residual effects of the iPUF intervention.

Tracking Information

NCT #
NCT04603014
Collaborators
Sequana Medical N.V.
Investigators
Principal Investigator: Christopher W. McIntyre, MD, PhD Lawson Research Institute