Peritoneal Dialysis-related InfectionNCT04950179

PDRI Rates Among CAPD Patients at a Tertiary University Hospital: A 5-Year Retrospective Study

An observational study of Peritoneal Dialysis-related Infection, run by Phramongkutklao College of Medicine and Hospital 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-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection rates, causative pathogens, appropriation of antibiotic use, treatment outcomes and trend in antimicrobial resistance… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peritoneal Dialysis-related Infection
What is being tested?: PDRI patients
How many people: 135 participants
Where: 1 siteThailand
Study dates: 24 Feb 2021to 14 Apr 2021
Phase: Observational
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

Study population: Patients who were undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) at CAPD clinic, Phramongkutklao Hospital.

Who may be able to join

Patients who were at least 18 years old.
Patients who were diagnosed with stage 5 chronic kidney disease (eGFR < 15 ml/min/1.73m^2).
Patients who were undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) at CAPD clinic, Phramongkutklao Hospital during January 1, 2016 to December 31, 2020.

Who cannot join

Patients with incomplete data records that invalid to include in the process of data analysis
Patients who were not treated and started their first CAPD at CAPD clinic, Phramongkutklao Hospital.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400

Other trials in Thailand

About this study

Official title: Peritoneal Dialysis-Related Infection Rates and Outcomes of Antibiotic Treatments Among Continuous Ambulatory Peritoneal Dialysis Patients at a Tertiary University Hospital: A 5-Year Retrospective Study

Conditions: Peritoneal Dialysis-related Infection
Being tested: PDRI patients
Keywords: Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Tunnel infection, Infection rate

What participants receive

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

PDRI patientsOther
The study was conducted by retrospective data collection from medical records of 135 continuous ambulatory peritoneal dialysis (CAPD) patients at Phramongkutklao Hospital from January 1, 2016 to December 31, 2020.

What is being measured

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

Rate of peritoneal dialysis-related infection
Retrospective data collection from patients' medical records
Measured: January 1, 2016 to December 31, 2020
Treatment outcomes of peritoneal dialysis-related infection
Retrospective data collection from patients' medical records
Measured: January 1, 2016 to December 31, 2020

Secondary outcomes (2)

Causative pathogens of peritoneal dialysis-related infection
Retrospective data collection from patients' medical records
Measured: January 1, 2016 to December 31, 2020
Appropriation of antibiotic use in the treatments of peritoneal dialysis-related infection
Retrospective data collection from patients' medical records
Measured: January 1, 2016 to December 31, 2020

Timeline

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

24 Feb 202114 Apr 2021

First posted6 Jul 2021
Study start24 Feb 2021
Primary completion11 Mar 2021
Study completion14 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Peritoneal Dialysis-related InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04950179
Sponsor's protocol ID: PDRI-2020
Status last verified: Jul 2021
First submitted: 25 Jun 2021
Last updated: 12 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Luvira V, Satirapoj B, Supasyndh O, Chaiprasert A, Ruangkanchanasetr P, Nata N, Kanjanakul I, Supaporn T, Choovichian P, Bijaphala S, Luvira U, Phiboonbanakit D. A single-centre experience: peritoneal dialysis-related infections in patients on long-term dialysis. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S30-6.
PubMed 22043564
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
Perl J, Fuller DS, Bieber BA, Boudville N, Kanjanabuch T, Ito Y, Nessim SJ, Piraino BM, Pisoni RL, Robinson BM, Schaubel DE, Schreiber MJ, Teitelbaum I, Woodrow G, Zhao J, Johnson DW. Peritoneal Dialysis-Related Infection Rates and Outcomes: Results From the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Am J Kidney Dis. 2020 Jul;76(1):42-53. doi: 10.1053/j.ajkd.2019.09.016. Epub 2020 Jan 10.
PubMed 31932094
Wang HH, Huang CH, Kuo MC, Lin SY, Hsu CH, Lee CY, Chiu YW, Chen YH, Lu PL. Microbiology of peritoneal dialysis-related infection and factors of refractory peritoneal dialysis related peritonitis: A ten-year single-center study in Taiwan. J Microbiol Immunol Infect. 2019 Oct;52(5):752-759. doi: 10.1016/j.jmii.2018.10.013. Epub 2019 Jan 8.
PubMed 30665844
Chen HC, Shieh CC, Sung JM. Increasing Staphylococcus Species Resistance in Peritoneal Dialysis-Related Peritonitis over a 10-Year Period in a Single Taiwanese Center. Perit Dial Int. 2018 Jul-Aug;38(4):266-270. doi: 10.3747/pdi.2017.00226.
PubMed 29987065
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
Szeto CC, Li PK, Johnson DW, Bernardini J, Dong J, Figueiredo AE, Ito Y, Kazancioglu R, Moraes T, Van Esch S, Brown EA. ISPD Catheter-Related Infection Recommendations: 2017 Update. Perit Dial Int. 2017 Mar-Apr;37(2):141-154. doi: 10.3747/pdi.2016.00120. No abstract available.
PubMed 28360365
Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.
PubMed 27282851

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peritoneal Dialysis-Related Infection Rates and Outcomes of Antibiotic Treatments Among Continuous Ambulatory Peritoneal Dialysis Patients at a Tertiary University Hospital: A 5-Year Retrospective Study
ClinicalTrials.gov ID: NCT04950179
Acronym / sponsor ID: PDRI-2020
Conditions: Peritoneal Dialysis-related Infection
Keywords: Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Tunnel infection, Infection rate
Study type: Observational
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
Collaborators: Silpakorn University
Study start: 24 Feb 2021 (actual)
Primary completion: 11 Mar 2021 (actual)
Study completion: 14 Apr 2021 (actual)
First posted: 6 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who were undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) at CAPD clinic, Phramongkutklao Hospital.

Key inclusion criteria (3 listed)

Patients who were at least 18 years old.
Patients who were diagnosed with stage 5 chronic kidney disease (eGFR < 15 ml/min/1.73m^2).
Patients who were undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) at CAPD clinic, Phramongkutklao Hospital during January 1, 2016 to December 31, 2020.

Key exclusion criteria (2 listed)

Patients with incomplete data records that invalid to include in the process of data analysis
Patients who were not treated and started their first CAPD at CAPD clinic, Phramongkutklao Hospital.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PDRI patientsThe study was conducted by retrospective data collection from medical records of 135 continuous ambulatory peritoneal dialysis (CAPD) patients at Phramongkutklao Hospital from January 1, 2016 to December 31, 2020.	Other	–

Primary outcome

Rate of peritoneal dialysis-related infection
Time frame: January 1, 2016 to December 31, 2020
Retrospective data collection from patients' medical records
Treatment outcomes of peritoneal dialysis-related infection
Time frame: January 1, 2016 to December 31, 2020
Retrospective data collection from patients' medical records

2 secondary outcomes

Causative pathogens of peritoneal dialysis-related infection
Time frame: January 1, 2016 to December 31, 2020
Appropriation of antibiotic use in the treatments of peritoneal dialysis-related infection
Time frame: January 1, 2016 to December 31, 2020

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
Background: PubMed 22043564Luvira V, Satirapoj B, Supasyndh O, Chaiprasert A, Ruangkanchanasetr P, Nata N, Kanjanakul I, Supaporn T, Choovichian P, Bijaphala S, Luvira U, Phiboonbanakit D. A single-centre experience: peritoneal dialysis-related infections in patients on long-term dialysis. J Med Assoc Thai. 2011 Sep;94 Suppl 4:S30-6.
Background: PubMed 22043560Kanjanabuch 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.
Background: PubMed 31932094Perl J, Fuller DS, Bieber BA, Boudville N, Kanjanabuch T, Ito Y, Nessim SJ, Piraino BM, Pisoni RL, Robinson BM, Schaubel DE, Schreiber MJ, Teitelbaum I, Woodrow G, Zhao J, Johnson DW. Peritoneal Dialysis-Related Infection Rates and Outcomes: Results From the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Am J Kidney Dis. 2020 Jul;76(1):42-53. doi: 10.1053/j.ajkd.2019.09.016. Epub 2020 Jan 10.
Background: PubMed 30665844Wang HH, Huang CH, Kuo MC, Lin SY, Hsu CH, Lee CY, Chiu YW, Chen YH, Lu PL. Microbiology of peritoneal dialysis-related infection and factors of refractory peritoneal dialysis related peritonitis: A ten-year single-center study in Taiwan. J Microbiol Immunol Infect. 2019 Oct;52(5):752-759. doi: 10.1016/j.jmii.2018.10.013. Epub 2019 Jan 8.
Background: PubMed 29987065Chen HC, Shieh CC, Sung JM. Increasing Staphylococcus Species Resistance in Peritoneal Dialysis-Related Peritonitis over a 10-Year Period in a Single Taiwanese Center. Perit Dial Int. 2018 Jul-Aug;38(4):266-270. doi: 10.3747/pdi.2017.00226.
Background: PubMed 20628102Li 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.
Background: PubMed 28360365Szeto CC, Li PK, Johnson DW, Bernardini J, Dong J, Figueiredo AE, Ito Y, Kazancioglu R, Moraes T, Van Esch S, Brown EA. ISPD Catheter-Related Infection Recommendations: 2017 Update. Perit Dial Int. 2017 Mar-Apr;37(2):141-154. doi: 10.3747/pdi.2016.00120. No abstract available.
Background: PubMed 27282851Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamila Tasanavipas, MD study chair

Phramongkutklao Hospital and College of Medicine

Daraporn Rungprai, BCP study director

Faculty of Pharmacy, Silpakorn University

Vorada Pengsong principal investigator

Faculty of Pharmacy, Silpakorn University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peritoneal Dialysis-related Infection, run by Phramongkutklao College of Medicine and Hospital 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 3 inclusion and 2 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 12 Jul 2021. 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?

Rate of peritoneal dialysis-related infection (time frame: January 1, 2016 to December 31, 2020). The study lists 2 primary outcomes in all. 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 NCT04950179, which also lists 8 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 12 Jul 2021.