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Clinical Trial Summary

Patients with kidney failure rely on dialysis for sodium and fluid removal. The importance of a sodium and fluid balance in patients with kidney disease is very important. Excess volume has been consistently associated with cardiovascular morbidity and mortality. Many peritoneal dialysis (PD) patients need large volumes of dextrose or Icodextrin based solutions to achieve fluid removal. Commonly used PD solutions also have high sodium concentrations to limit sugar absorption. These PD fluids can reduce the amount of sodium removed and may eventually lead to water retention over time with possible adverse outcomes. This research study is being conducted to determine if a single eight-hour dwell of intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution is safe, tolerable and effective in achieving sodium and volume removal in PD patients.

Clinical Trial Description

This study is a phase 1 interventional study in Peritoneal Dialysis Patients. We will recruit 10 participants. This study involves one visit at the London Health Sciences Centre University Hospital lasting approximately 9 hours. Study participants will receive one in-center PD dwell, consisting of peritoneal instillation of a sodium-free 30% Icodextrin/10% dextrose solution via their Tenckhoff catheter; the solution will be dwelling in the study patient's peritoneal cavity for a maximum of 8 hours as tolerated, at the end of which the solution will be drained. Participants will be monitored during administration of the study solution, during dwell and up to one hour after the Peritoneal Dialysis fluid is drained. Study participants will also undergo: - Clinical blood pressure and heart rate monitoring: baseline + every 15 minutes for the first two hours; then every 30 minutes up until 1 hour post complete peritoneal solution drain - Continuous Finapress hemodynamic monitoring (until 1 hour post peritoneal solution drain) - Pain Monitoring throughout the study visit (Five point verbal scale and McGill Pain Questionnaire) - Blood collection: baseline, 1, 2, 4, 8 hours into the dwell and 1 hour after the end of drain - Peritoneal dialysate collection: 1, 2, 4, 8 hours into the dwell - Urine collection throughout visit. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05185999
Study type Interventional
Source Lawson Health Research Institute
Contact Christopher W McIntyre, MD/PHD
Phone 519-685-8500
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date March 1, 2022
Completion date December 1, 2023

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