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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Phase I Study to Evaluate the Short-term Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution With 30% Icodextrin and 10% Dextrose in Patients in Peritoneal Dialysis, on a Preliminary Basis

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: 30% icodextrin and 10% dextrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients covered by the Mexican Social Security Department. Adults over the age of eighteen. Patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis. Patients with a functional peritoneal dialysis catheter. Patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis) Patients who wish to participate and who sign the informed consent. If the peritoneal dialysis catheter and the transfer line are compatible with the peritoneal dialysis bag that has a simple luer male connector. If treating doctors consider their patient to be clinically euvolemic. If patients have undergone a peritoneal equilibrium test and their dialysis prescription has not been changed since the test was carried out Exclusion criteria: Diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%). Active infection. Serum sodium prior to the study less than 130 mmol/l. Serum bicarbonate prior to the study less than 18 mmol/l. Patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose Hemoglobin less than 8 g/dl. Active bleeding. Patients prescribed peritoneal dialysis who use a 4.25% dextrose solution at least once a day. Patients with a membrane defect or mechanical defect. Diastolic dysfunction with an increase in filling pressure according to the echocardiogram. Patients with active or suspected peritonitis according to the clinical criterion or their treating doctor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30% icodextrin and 10% dextrose<br>Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose | Drug: 30% icodextrin and 10% dextrose<br>* Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety defined as the number serious adverse events related to the investigational product | Safety will be described based on the number of serious adverse events that are determined to be related to the investigational product | During the 24 hour dwell | 
| Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain | Description of pain. Pain will be described in a scale from 0 to 4; 0 is no pain, 1 is mild pain, 2 is moderate pain, 3 is severe pain, and 4 is extreme pain. Pain will be assessed during infusion, then hourly during the 24 hour dwell, and during the draining | During the 24 hour dwell | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrafiltration | Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr dwell | During the 24 hour dwell | 
| Sodium excretion with ultrafiltration | Sodium excretion with ultrafiltration will be calculated by multiplying the mL obtained during the draining after the 24hr dwell by the sodium concentration in a sample of peritoneal fluid | During the 24 hour dwell |