| Trial ID: | L0072 |
| Source ID: | NCT05780086
|
| Associated Drug: |
30% Icodextrin And 10% Dextrose
|
| Title: |
Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases
|
| Interventions: |
DRUG: 30% icodextrin and 10% dextrose
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Instituto Mexicano del Seguro Social | Collaborators: Sequana Medical N.V.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-02-03
|
| Completion Date: |
2023-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-28
|
| Locations: |
Hospital de Cardiología, Centro Médico Nacional Siglo XXI, Ciudad de México, 06720, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT05780086
|
