NCT04950179

Brief 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 of causative pathogens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

15 days

First QC Date

June 25, 2021

Last Update Submit

July 6, 2021

Conditions

Keywords

Peritoneal dialysis-related infectionInfectious peritonitisExit-site infectionTunnel infectionInfection rate

Outcome Measures

Primary Outcomes (2)

  • Rate of peritoneal dialysis-related infection

    Retrospective data collection from patients' medical records

    January 1, 2016 to December 31, 2020

  • Treatment outcomes of peritoneal dialysis-related infection

    Retrospective data collection from patients' medical records

    January 1, 2016 to December 31, 2020

Secondary Outcomes (2)

  • Causative pathogens of peritoneal dialysis-related infection

    January 1, 2016 to December 31, 2020

  • Appropriation of antibiotic use in the treatments of peritoneal dialysis-related infection

    January 1, 2016 to December 31, 2020

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (8)

  • 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.

    PMID: 22043564BACKGROUND
  • 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.

    PMID: 22043560BACKGROUND
  • 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.

    PMID: 31932094BACKGROUND
  • 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.

    PMID: 30665844BACKGROUND
  • 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.

    PMID: 29987065BACKGROUND
  • 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.

    PMID: 20628102BACKGROUND
  • 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.

    PMID: 28360365BACKGROUND
  • 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.

    PMID: 27282851BACKGROUND

Study Officials

  • Pamila Tasanavipas, MD

    Phramongkutklao Hospital and College of Medicine

    STUDY CHAIR
  • Daraporn Rungprai, BCP

    Faculty of Pharmacy, Silpakorn University

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 6, 2021

Study Start

February 24, 2021

Primary Completion

March 11, 2021

Study Completion

April 14, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations