The Difference Between Daily and Alternative Day Use of Icodextrin

NCT ID: NCT05943470

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-28

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.

Conditions

Peritoneal Dialysis Solution Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

daily

daily use of one exchange of icodextin as long dwell

Group Type: ACTIVE_COMPARATOR

Icodextrin Peritoneal Dialysis Solution

Intervention Type: DRUG

alternative day use of icodextrin comparing with daily use of icodextrin

alternative day

alternative day use of one exchange of icodextin as long dwell

Group Type: EXPERIMENTAL

Icodextrin Peritoneal Dialysis Solution

Intervention Type: DRUG

alternative day use of icodextrin comparing with daily use of icodextrin

Interventions

Icodextrin Peritoneal Dialysis Solution

alternative day use of icodextrin comparing with daily use of icodextrin

Intervention Type: DRUG

Other Intervention Names

Extraneal

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zanzhe Yu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LY2023-083

Identifier Type: -

Identifier Source: org_study_id