An observational study in Peritoneal Dialysis (PD), sponsored by First Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational
To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD
First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 162 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Incident APD patients of multiple centesr who meet the inclusion criteria will be recruited.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the APD group, the PD team did not have access to the information transmitted by the RPM device; the management of patients in the APD group was carried out in the usual way.
Doctors and nurses were instructed to review daily the data provided by the IRPM-APD device for IRPM-APD arms patients. In detail, daily data includes the day and time of connection, the duration of treatment per day, total exchange volume, the number of cycles, use or not of wet day (i.e. daytime exchange in the preceding day), dialysate volume infused, total dwell time, dwell time per exchange, actual time for filling and draining per exchange, drain volume per dwell and total treatment, cycle profile, total and dwell ultrafiltration, and number of events per treatment. The number and reason for alarms, events and bypass drain were also recorded and reviewed.
Other: Integrated remote patient monitoring (IRPM)
IRPM provided information gathered by RPM of treatment data day-by-day, and achieved higher-frequency information feedback and clinical decision support. Additionally, the current knowledge about the effects of RPM in APD limited real-world research.
Composite indices were constructed based on four SONG-PD (Standardized Outcomes in Nephrology-Peritoneal Dialysis) core outcomes: mortality, cardiovascular (CV) diseases, PD infection and technique survival, complemented by SONG-PD middle.
Primary endpoints were time to the first event of Composite Index, including mortality (all-cause mortality and CV-related mortality), transferring to hemodialysis (technique failure), and peritonitis.
Time frame: From date of randomization until the date of first event, whichever came first, assessed at least 24 months.
Adverse events
Rate of adverse events in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months
Hospitalizations linked to adverse events possibly related to potentially preventable causes such as fluid overload (edema, hypertension and heart failure)
Rate of hospitalizations in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months
Unplanned visits, defined as any unscheduled medical contacts (including outpatient visits, emergency room visits, or phone calls) made by peritoneal dialysis patients because of unexpected health issues, beyond the routine follow-up schedule.
Rate of unplanned visits in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.
Nutritional condition (evaluated by SGA)
Change of nutritional condition in one year.
Time frame: From date of randomization until study completion, assessed at least 24 months.
Quality of life (evaluated by SF36)
The Short Form 36-item Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status and fewer limitations.
Time frame: Change of quality of life in one year.
Residual renal function decline
Rate of residual renal function decline in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.
Consumption of medical resources
Medical resource consumption is measured by the time of nurse reviews of remote monitoring data and alarm events.
Time frame: From date of randomization until study completion, assessed at least 24 months.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital, Sun Yat-Sen University →