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End-Stage Kidney DiseaseCLIP-SPNCT02755610

Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis

A study testing PD Product Check List in people with End-Stage Kidney Disease and Peritonitis, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-Stage Kidney Disease, Peritonitis
What is being tested?
PD Product Check List
Could I receive a placebo?
No, everyone receives an active treatment
How many people
880 participants
Where
1 siteThailand
Study dates
2 May 2016to May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ESRD patients who start peritoneal dialysis not longer than one month and participate in PDOPPS study

Who cannot join

  • ESRD patients who receive only hemodialysis
  • ESRD patients who receive emergency peritoneal dialysis
  • Illiterate ESRD patients or their caregivers

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Faculty of Medicine, Chulalongkorn University

    Bangkok, 10330

Other trials in Thailand

About this study

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.

Read the detailed description

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.

Being tested
PD Product Check List
Keywords
Peritoneal Dialysis, Checklist
Medical subject headings
Kidney Failure, Chronic, Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD Product Check ListOther

    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.

Study groups in NCT02755610
Study groupRoleWhat they receive
PD Product Check ListExperimentalPD 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.
Receives: Other: PD Product Check List
ControlNo interventionStandard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peritonitis Incidence Rate

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)
  1. Product Defect Incidence

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study start2 May 2016
  3. Primary completionMay 2017
  4. Study completionMay 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants in the Study Arm receive standard care and a paper check list to record product defect information Participants in the Control Arm receive standard care
Masking
None (open label)
Enrolment
880 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02755610
Sponsor's protocol ID
CLIP-SP
Acronym
CLIP-SP
Status last verified
Oct 2026
First submitted
9 Feb 2016
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dhanakijcharoen P, Sirivongs D, Aruyapitipan S, Chuengsaman P, Lumpaopong A. The "PD First" policy in Thailand: three-years experiences (2008-2011). J Med Assoc Thai. 2011 Sep;94 Suppl 4:S153-61.

    PubMed 22043584
  • Praditpornsilpa K, Lekhyananda S, Premasathian N, Kingwatanakul P, Lumpaopong A, Gojaseni P, Sakulsaengprapha A, Prasithsirikul W, Phakdeekitcharoen B, Lelamali K, Teepprasan T, Aumanaphong C, Leerawat B, Pongpiyadej J, Srangsomvong S, Kanjanabuch T, Eiam-Ong S, Vareesaengthip K, Lumlertkul D. Prevalence trend of renal replacement therapy in Thailand: impact of health economics policy. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S1-6.

    PubMed 22043559
  • Liu FX, Gao X, Inglese G, Chuengsaman P, Pecoits-Filho R, Yu A. A Global Overview of the Impact of Peritoneal Dialysis First or Favored Policies: An Opinion. Perit Dial Int. 2015 Jul-Aug;35(4):406-20. doi: 10.3747/pdi.2013.00204. Epub 2014 Jul 31.

    PubMed 25082840
  • Wong HS, Ong LM, Lim TO, Hooi LS, Morad Z, Ghazalli R, Shaariah W, Lim YN, Ahmad G, Goh BL, Liaw L, Pee S, Lee ML. A randomized, multicenter, open-label trial to determine peritonitis rate, product defect, and technique survival between ANDY-Disc and UltraBag in patients on CAPD. Am J Kidney Dis. 2006 Sep;48(3):464-72. doi: 10.1053/j.ajkd.2006.05.008.

    PubMed 16931220
  • Kanjanabuch T, Chancharoenthana W, Katavetin P, Sritippayawan S, Praditpornsilpa K, Ariyapitipan S, Eiam-Ong S, Dhanakijcharoen P, Lumlertgul D. The incidence of peritoneal dialysis-related infection in Thailand: a nationwide survey. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S7-12.

    PubMed 22043560
  • Amornnimit W, Pongpirul K, Sampatanukul P, Tungsanga K, Tosukhowong P, Kanjanabuch T. Black-stained peritoneal dialysis tubing: a national survey. Perit Dial Int. 2013 Nov-Dec;33(6):704-7. doi: 10.3747/pdi.2012.00167. No abstract available.

    PubMed 24335129
  • Pongpirul K, Pongpirul WA, Kanjanabuch T. Potential causes of black-stained peritoneal dialysis tubing: an analysis from nurse practitioner's prospect. BMC Res Notes. 2014 Jul 6;7:434. doi: 10.1186/1756-0500-7-434.

    PubMed 24997794
  • Treamtrakanpon W, Katavetin P, Yimsangyad K, Keawsinark P, Sanganunttakan S, Pandon S, Buddeewong D, Prakot A, Khumsupo C, Thamsutee N, Yaibuaiam R, Khumwong S, Towannang P, Theerasin Y, Mahatnan N, Eiam-Ong S, Kanjanabuch T. From the "PD First" policy to the innovation in PD care. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S13-8.

    PubMed 22043561
  • Bernardini J, Price V, Figueiredo A; International Society for Peritoneal Dialysis (ISPD) Nursing Liaison Committee. Peritoneal dialysis patient training, 2006. Perit Dial Int. 2006 Nov-Dec;26(6):625-32. No abstract available.

    PubMed 17047225
  • Perl J, Davies SJ, Lambie M, Pisoni RL, McCullough K, Johnson DW, Sloand JA, Prichard S, Kawanishi H, Tentori F, Robinson BM. The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis. Perit Dial Int. 2016 May-Jun;36(3):297-307. doi: 10.3747/pdi.2014.00288. Epub 2015 Nov 2.

    PubMed 26526049
  • Li PK, Szeto CC, Piraino B, Bernardini J, Figueiredo AE, Gupta A, Johnson DW, Kuijper EJ, Lye WC, Salzer W, Schaefer F, Struijk DG; International Society for Peritoneal Dialysis. Peritoneal dialysis-related infections recommendations: 2010 update. Perit Dial Int. 2010 Jul-Aug;30(4):393-423. doi: 10.3747/pdi.2010.00049. No abstract available.

    PubMed 20628102
  • Vonesh EF. Modelling peritonitis rates and associated risk factors for individuals on continuous ambulatory peritoneal dialysis. Stat Med. 1990 Mar;9(3):263-71. doi: 10.1002/sim.4780090309.

    PubMed 2188325

Questions about this trial

What is this clinical trial studying?

A study testing PD Product Check List in people with End-Stage Kidney Disease and Peritonitis, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peritonitis Incidence Rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755610, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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