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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose
Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Mexico City, Mexico
RECRUITINGSafety 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
Time frame: 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
Time frame: During the 24 hour dwell
Ultrafiltration
Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr dwell
Time frame: 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
Time frame: During the 24 hour dwell
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