- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04950179
PDRI Rates Among CAPD Patients at a Tertiary University Hospital: A 5-Year Retrospective Study
July 6, 2021 updated by: Phramongkutklao College of Medicine and Hospital
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
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 of causative pathogens.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
135
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Ratchathewi, Bangkok, Thailand, 10400
- Phramongkutklao Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who were undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) at CAPD clinic, Phramongkutklao Hospital.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of peritoneal dialysis-related infection
Time Frame: January 1, 2016 to December 31, 2020
|
Retrospective data collection from patients' medical records
|
January 1, 2016 to December 31, 2020
|
Treatment outcomes of peritoneal dialysis-related infection
Time Frame: January 1, 2016 to December 31, 2020
|
Retrospective data collection from patients' medical records
|
January 1, 2016 to December 31, 2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Causative pathogens of peritoneal dialysis-related infection
Time Frame: January 1, 2016 to December 31, 2020
|
Retrospective data collection from patients' medical records
|
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
|
Retrospective data collection from patients' medical records
|
January 1, 2016 to December 31, 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Pamila Tasanavipas, MD, Phramongkutklao hospital and College of Medicine
- Study Director: Daraporn Rungprai, BCP, Faculty of Pharmacy, Silpakorn University
- Principal Investigator: Vorada Pengsong, Faculty of Pharmacy, Silpakorn University
- Principal Investigator: Vattanai Dhamnimitchok, Faculty of Pharmacy, Silpakorn University
- Principal Investigator: Vilai Wisuthip, Faculty of Pharmacy, Silpakorn University
- Principal Investigator: Supichaya Hluangbumroong, Faculty of Pharmacy, Silpakorn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Perit Dial Int. 2011 Sep-Oct;31(5):512.
- 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.
- 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. Erratum In: Perit Dial Int. 2018 Jul-Aug;38(4):313.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2021
Primary Completion (Actual)
March 11, 2021
Study Completion (Actual)
April 14, 2021
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
June 25, 2021
First Posted (Actual)
July 6, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 6, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDRI-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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