Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection
Study Details
Study Description
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, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period. Rate of catheter removal, time to first peritoneal dialysis-related infection after apply gentamicin cream.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mupirocin and Gentamicin 2% mupirocin ointments apply at exit-site once daily after wound cleaning before recruit in the study then use 0.1% gentamicin cream apply at exit-site once daily after wound cleaning after entry to the study. |
Drug: Mupirocin
Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021
Other Names:
Drug: Gentamicin
Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of Exit-site infection in mupirocin compared with gentamicin group [All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.]
Exit-site infection diagnosis by physician. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group.
- Rate of Infectious peritonitis in mupirocin compared with gentamicin group [All infectious peritonitis episodes occurred last year in mupirocin group and all infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.]
Infectious peritonitis diagnosis by physicians. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Secondary Outcome Measures
- Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group [All pathogenic organisms of exit-site infection episodes occurred last year in mupirocin group and all pathogenic organisms of exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.]
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
- Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group [All pathogenic organisms of infectious peritonitis episodes occurred last year in mupirocin group and all pathogenic organisms of infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.]
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
- Percentage of catheter removal due to peritoneal dialysis-related infection [Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.]
Prospective data collection from patient's medical records in gentamicin group
- Time to first peritoneal dialysis-related infection after gentamicin application [Prospective period at least 1 year after entry to the study.]
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group. Peritoneal-related infection diagnosis by physicians. Prospective data collection from patient's medical records in gentamicin group
- Drug susceptibility of causative pathogens of peritoneal dialysis-related infection [Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.]
Drug susceptibility test by broth micro-dilution and E-test. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age greater than or equal to 20 years
-
End stage renal disease patients on peritoneal dialysis follow up at Phramongkutklao hospital's peritoneal dialysis clinic between January 1, 2021 to March 31, 2023
-
Start peritoneal dialysis or follow up at Phramongkutklao hospital's peritoneal dialysis clinic at least 90 days before recruited
-
Use topical mupirocin ointment for prevention of peritoneal dialysis-related infection between January 1, 2021 to December 31, 2021
-
Can be used LINE application throughout the study
Exclusion Criteria:
-
Allergy to gentamicin or components
-
Previous systemic antibiotics use within 90 days before recruited
-
Previous peritoneal dialysis-related infection within 28 days before recruited
-
Immunosuppressants used
-
Prospective follow up less than 2 months
-
Don't sign informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phramongkutklao Hospital | Ratchathewi | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- Phramongkutklao College of Medicine and Hospital
- Silpakorn University Faculty of Pharmacy
Investigators
- Study Chair: Ittaprach Yimsuk, PharmD, College of Pharmacy, Rangsit university
- Study Director: Pamila Tasanavipas, MD, Phramongkutklao hospital and College of Medicine
- Study Director: Daraporn Rungprai, BCP, Faculty of Pharmacy, Silpakorn University
- Study Director: Wichai Santimaleeworagun, BCP, Faculty of Pharmacy, Silpakorn University
- Principal Investigator: Kulthida Chaijumroen, B.N.S., Phramongkutklao hospital and College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PDRI-2021