Clinical trial NCT05780086: Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Kidney Diseases
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Sequana Medical N.V.
First posted: 2023-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety defined as the number serious adverse events related to the investigational product
timeFrame: During the 24 hour dwell
measure: Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain
timeFrame: During the 24 hour dwell
Secondary outcomes:
measure: Ultrafiltration
timeFrame: During the 24 hour dwell
measure: Sodium excretion with ultrafiltration
timeFrame: During the 24 hour dwell
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Study officials:
affiliation: Affiliated to Heart Failure Clinic
name: Juan B Ivey Miranda, MD
role: PRINCIPAL_INVESTIGATOR
References: