NCT05185999

Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients

A Phase 1 Interventional Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Intraperitoneal 30% Icodextrin/10% Dextrose Solution in Peritoneal Dialysis Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a phase 1 interventional study in Peritoneal Dialysis Patients. Investigators 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 participant'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.

Conditions

• Chronic Kidney Failure

Interventions

Type	Name	Description
DRUG	Icodextrin/Dextrose	Single 8 hour dwell of a 500mL intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution

Timeline

• Start date: 2022-10-17
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2022-01-11
• Last updated: 2024-01-29

Locations

2 sites across 1 country: Canada