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The Difference Between Daily and Alternative Day Use of Icodextrin

The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05943470
Enrollment
74
Registered
2023-07-13
Start date
2023-08-01
Completion date
2024-12-28
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis Solution Adverse Reaction

Brief summary

Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients. However, icodextrin metabolites are known to accumulate to some extent in the body, resulting in less ultrafiltration with long-term icodextrin use comparing with newly use. Therefore, the investigator hypothesized that a single dose of icodextrin would produce more ultrafiltration volume with the use of icodextrin dialysate on alternate days than with the use of icodextrin dialysate on daily uses.

Detailed description

1. Patients who met the inclusion criteria will be enrolled in this study. 2. Randomization. 3. Treatment A: daily icodextrin for 2 weeks. Treatment B: icodextrin is used every other day and original glucose-based dialysate is used every other day for a total of 2 weeks. The duration of icodextrin exchange is unchanged from the participants' original dialysate exchange regimen (typically, 8 to 14 hours). The interval is two weeks (the original dialysate was resumed). Participants would receive treatment A-B or B-A, depending on randomization. 4. Participants would record daily peritoneal ultrafiltration volume, long dwell ultrafiltration volume, dialysis prescription, urine volume, body weight, home blood pressure monitoring and complaints of discomfort. 5. Before the start of treatment (day 0), after the end of treatment period 1 (day14), at the end of washout period (day28), and at the end of treatment period 2 (day42), blood samples are collected for blood glucose, blood lipids, BNP, amylase, blood electrolytes, alkaline phosphatase. The participants' weight, blood pressure, dialysis prescription, daily ultrafiltration volume, urine volume, long dwell ultrafiltration volume and BCM measurement results would be recorded on the visit day. In the last 10 enrolled patients, blood samples would be collected for detection of icodextrin metabolites. After the end of treatment period 2, participants could choose the prescription of dialysate according to their own wishes and would be followed up for another 2 weeks.

Interventions

alternative day use of icodextrin comparing with daily use of icodextrin

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 1\. End-stage renal failure 2\. Patients with regular peritoneal dialysis in our center 3\. 18-75 years old 4\. Patients who currently use glucose dialysate for prolonged abdominals 5\. Sign informed consent

Exclusion criteria

* 1\. The expected survival time is less than 3 months 2\. Known peritoneal dialysis tube dysfunction 3\. Peritonitis occurred within one month 4\. Known peritoneal effusion 5\. Known allergy to icodextrin

Design outcomes

Primary

MeasureTime frameDescription
ultrafiltration measured in ml2 weeksultrafiltration volume for single icodextrin dwell

Secondary

MeasureTime frameDescription
daily treatment cost measured in Chinese Yuan2 weeksdaily treatment cost

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026