An observational Study in Optimising Intraperitoneal Gentamicin in peritoneal dialysis patients with peritonitis

Not Applicable

Recruiting

• Conditions: Gentamicin dosing in Peitonitis in peritoneal dialysis patients; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12609000446268
• Lead Sponsor: Department of Renal Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-Age >18 years
-On Peritoneal Dialysis (Continuos ambulatory peritoneal dialysis or Automated Peritoneal dialysis ) for more than 1 month
-Prescription of intraperitoneal gentamicin according to current peritonitis treatment guidelines

Exclusion Criteria

-<2 weeks since a course of antibiotics for a previous episode of peritonitis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the pharmacokinetics of gentamicin administered intraperitoneally in peritoneal dialysis patients with peritonitis<br><br>Sample analysis<br>Plasma and dialysate samples of gentamicin will be measured by the Burns Trauma and Critical Care Research Centre (The University of Queensland) using validated liquid chromatography tandem-mass spectrometry (LC-MS/MS) analytical assays.<br><br><br><br>Data analysis<br>Sample analysis results will be interpreted using pharmacokinetic computer software (NONMEM) to develop a pharmacokinetic model for intraperitoneally administered gentamicin. The model can then be used to undertake dosing simulations of different antibiotic doses to determine the best dosing recommendations for intraperitoneal gentamicin in peritoneal dialysis patients with peritonitis. The influence of demographic or clinical covariates will be assessed using the statistical program SPSS.[3 years from baselie]

Secondary Outcome Measures

Name	Time	Method
To develop a pharmacokinetic model that can be used to conduct dosing simulations and to develop dosing recommendations for intraperitoneal gentamicin dosing in peritonitis- <br>Sample analysis results will be interpreted using pharmacokinetic computer software (NONMEM) to develop a pharmacokinetic model for intraperitoneally administered gentamicin. The model can then be used to undertake dosing simulations of different antibiotic doses to determine the best dosing recommendations for intraperitoneal gentamicin in peritoneal dialysis patients with peritonitis.[3 years from baseline]