An interventional study of PD Product Check List in End-Stage Kidney Disease and Peritonitis, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Health services research
Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal Disease (ESRD) patients under the "PD First" policy of the Universal Coverage (UC) scheme. The increased demand has resulted in not only supply chain logistical problems, but also product quality concerns. Peritonitis, the main complication and checklist cause of failure in Continuous Ambulatory Peritoneal Dialysis (CAPD) patients, could be caused by a product defect. This cluster randomized trial will be conducted in 22 randomly selected PD centers in Thailand to assess if a checklist intervention could reduce peritonitis rate and increase the number of checklist product defect report.
Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal Disease (ESRD) patients under the "PD First" policy of the Universal Coverage (UC) scheme. The increased demand has resulted in not only supply chain logistical problems, but also product quality concerns. Peritonitis, the main complication and main cause of failure in CAPD patients, could be caused by a product defect.
PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
This cluster randomized trial will be conducted in 22 PD centers (anticipated 20-25 prevalent and 10-15 incidence PD cases per center) to answer the primary research question: is the checklist intervention effective in reducing peritonitis rate? The secondary research questions will also be considered: does the checklist help increase the number of product defect report?
Peritonitis incidence rate is the primary outcome, defined based on the International Society for Peritoneal Dialysis (ISPD) 2010 recommendation. Product defect incidence is the secondary outcome, measured by a number of incidence of product defect reported by the patients. Given no standard definition, a PD solution product will be considered defective if it is expired on the day of use, incorrect glucose concentration, abnormal clarity or color, physical abnormality of the box and/or the bag, or loose connector.
Because of the nature of the intervention, blinding is not possible. Cluster randomization will be performed to allocate 11 PD centers to the study group and the other 11 PD centers to control group. While all subjects will receive standard PD care, subjects in the study group will also receive the checklist plus a 30-minute orientation of how to use the checklist.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 880 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
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PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
Other: PD Product Check List
Standard care
PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
Peritonitis Incidence Rate
Time frame: through study completion, an average of 1 year
Product Defect Incidence
Time frame: through study completion, an average of 1 year
Plan to share: No
Ran from May 2016 to primary completion in May 2017, 12 months.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 12 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
Primary completion moved once since we started tracking on Sep 25, 2026: May 2024 → May 2017, on Oct 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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