Last updated 3 years 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 dextroseHemoglobin 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 Médico Nacional Siglo XXI
Recruiting
SponsorInstituto Mexicano del Seguro Social
Study typeInterventional
Conditions
Chronic kidney disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05780086
