## Protocol Section
### Identification Module
**NCT ID:** NCT04950179

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

#### Organization Study ID Info
**ID:** PDRI-2020
#### Organization
**Class:** OTHER
**Full Name:** Phramongkutklao College of Medicine and Hospital
### Status Module
#### Completion Date
**Date:** 2021-04-14

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-07-12

**Type:** ACTUAL

**Last Update Submit Date:** 2021-07-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-03-11

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-24

**Type:** ACTUAL

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2021-07-06
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-25
**Study First Submit QC Date:** 2021-06-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Silpakorn University

#### Lead Sponsor

**Class:** OTHER

**Name:** Phramongkutklao College of Medicine and Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Peritoneal Dialysis-related Infection

**Keywords:**

- Peritoneal dialysis-related infection

- Infectious peritonitis

- Exit-site infection

- Tunnel infection

- Infection rate

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 135

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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.

**Name:** PDRI patients

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Retrospective data collection from patients' medical records

**Measure:** Rate of peritoneal dialysis-related infection

**Time Frame:** January 1, 2016 to December 31, 2020

**Description:** Retrospective data collection from patients' medical records

**Measure:** Treatment outcomes of peritoneal dialysis-related infection

**Time Frame:** January 1, 2016 to December 31, 2020

#### Secondary Outcomes

**Description:** Retrospective data collection from patients' medical records

**Measure:** Causative pathogens of peritoneal dialysis-related infection

**Time Frame:** January 1, 2016 to December 31, 2020

**Description:** Retrospective data collection from patients' medical records

**Measure:** Appropriation of antibiotic use in the treatments of peritoneal dialysis-related infection

**Time Frame:** January 1, 2016 to December 31, 2020

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ratchathewi

**Country:** Thailand

**Facility:** Phramongkutklao Hospital

**State:** Bangkok

**Zip:** 10400

#### Overall Officials

**Official 1:**

**Affiliation:** Phramongkutklao Hospital and College of Medicine

**Name:** Pamila Tasanavipas, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Faculty of Pharmacy, Silpakorn University

**Name:** Daraporn Rungprai, BCP

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Faculty of Pharmacy, Silpakorn University

**Name:** Vorada Pengsong

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Faculty of Pharmacy, Silpakorn University

**Name:** Vattanai Dhamnimitchok

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Faculty of Pharmacy, Silpakorn University

**Name:** Vilai Wisuthip

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Faculty of Pharmacy, Silpakorn University

**Name:** Supichaya Hluangbumroong

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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:** 22043564

**Citation:** 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:** 22043560

**Citation:** 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:** 31932094

**Citation:** 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:** 30665844

**Citation:** 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:** 29987065

**Citation:** 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.

**PMID:** 20628102

**Citation:** 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:** 28360365

**Citation:** 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.

**PMID:** 27282851

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M13447

- Name: Peritonitis

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
