💬In plain words
What the trial is, and whether it could suit you
We hypothesize incremental peritoneal dialysis (incremental PD) protocol with icodextrin solution will help patients to achieve adequate ultrafiltration and adequate dialysis with less glucose exposure by manipulating a low frequency of exchanges, therefore prolong the time from incremental protocol to full dose protocol (Full dose dialysis is defined as a dialysis dose of more than 8 L (4 exchanges of 2 L) per day). The goal of this clinical trial is to investigate the effect of icodextrin postponing the shift of low dose to full dose dialysis in the first year of incremental peritoneal dialysis. The main questions are:
* The effect of icodextrin on the shift of low dose to full dose dialysis in the first year in patients on incremental peritoneal dialysis.
* The effect of icodextrin on clinical outcomes in patients on incremental peritoneal dialysis, such as the first episode of perit
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📋 Eligibility rules (as published)
Inclusion Criteria:
* Age ≥ 18 years old;
* The estimated glomerular filtration rate (eGFR) ≥ 3ml/min·1.73m2 when enrolled;
* The 24-hour urine volume ≥ 500ml when enrolled;
* The patient or his lawful representative is able to receive and complete training of home peritoneal dialysis;
* Patients were able to follow the follow-up schedule and other requirements of the study;
* Patients can come to the peritoneal dialysis center for regular follow-up (once every 2 months or more);
* Participants were expected to remain on peritoneal dialysis for at least 13 months;
* Patients with good compliance;
* Informed consent was obtained.
Exclusion Criteria:
* Treated with both peritoneal dialysis and hemodialysis;
* Patients who have previously received a kidney transplant and have been receiving immunosuppressive therapy;
* Contraindications to bioelectrical impedance analysis (BIA) testing (e.g., amputation, use of a pacemaker or prosthesis);
* Allergy to Icodextrin, starch and starch products, or suffer from glycogen storage disease;
* Contraindications for the use of icodextrin;
* HIV-positive participants;
* Patients with tumors or other serious diseases have a life expectancy of less than one year;
* Mental illness that interferes with the patient's understanding of the test requirements and completion of the test process;
* Chronic wasting diseases such as tuberculosis, cirrhosis, hematological or other malignancies;
* Patients who are pregnant, intending to become pregnant, or breastfeeding during the study period;
* The patients had a history of drug abuse or alcoholism 2 years before the screening period;
* Patients who are unwilling or not expected to fully comply with the visits and evaluations required by the protocol;
* Patients who, in the investigator's judgment, have other serious or acute medical conditions that may prevent them from participating in the study.
💊
What it tests
- Icodextrin Peritoneal Dialysis Solution
- Hypertonic Dextrose solution
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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