Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution

Instituto Mexicano del Seguro Social

Status and phase: Enrolling; Phase 1

Conditions: Chronic Kidney Diseases

Treatments: Drug: 30% icodextrin and 10% dextrose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05780086

R-2022-785-034

Details and patient eligibility

About

This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis

Full description

Phase I clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. Patients will be hospitalized for the study. The study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients covered by the Mexican Social Security Department.
2. Adults over the age of eighteen.
3. Patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis.
4. Patients with a functional peritoneal dialysis catheter.
5. Patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis)
6. Patients who wish to participate and who sign the informed consent.
7. If the peritoneal dialysis catheter and the transfer line are compatible with the peritoneal dialysis bag that has a simple luer male connector.
8. If treating doctors consider their patient to be clinically euvolemic.
9. If patients have undergone a peritoneal equilibrium test and their dialysis prescription has not been changed since the test was carried out

Exclusion criteria

1. Diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%).
2. Active infection.
3. Serum sodium prior to the study less than 130 mmol/l.
4. Serum bicarbonate prior to the study less than 18 mmol/l.
5. Patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose
6. Hemoglobin less than 8 g/dl.
7. Active bleeding.
8. Patients prescribed peritoneal dialysis who use a 4.25% dextrose solution at least once a day.
9. Patients with a membrane defect or mechanical defect.
10. Diastolic dysfunction with an increase in filling pressure according to the echocardiogram.
11. Patients with active or suspected peritonitis according to the clinical criterion or their treating doctor.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

30% icodextrin and 10% dextrose

Experimental group

Description:

Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose

Treatment:

Drug: 30% icodextrin and 10% dextrose