Overview

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

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Lawson Health Research Institute

Treatments:

Icodextrin

Criteria

Inclusion Criteria:

- Functioning Tenckhoff catheter

- Stable PD prescription regimen (continuous ambulatory PD or automated PD) for the past
month

- Age 18 years or older

- Willing and able to provide informed consent

Exclusion Criteria:

- Type 1 or uncontrolled diabetes mellitus

- Active infections

- Pre-study serum sodium <130 mmol/L

- Serum bicarbonate < 18mmol/L

- Patients with standard PD prescriptions relying exclusively on lowest glucose containg
fluid