Last updated 21 months ago

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

10 patients around the world

Available in Mexico

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.

Instituto Mexicano del Seguro Social

1Research sites

10Patients around the world

This study is for people with

Renal disease

Chronic kidney disease

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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

: 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.

Sites

Centro Medico Nacional Siglo XXI

Recruiting

Av. Cuauhtémoc 330, Doctores, Cuauhtémoc, Ciudad de México

SponsorInstituto Mexicano del Seguro Social

Study typeInterventional

Conditions

Chronic kidney disease

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05780086