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Trial registered on ANZCTR


Registration number
ACTRN12609000446268
Ethics application status
Approved
Date submitted
22/05/2009
Date registered
12/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational Study in Optimising Intraperitoneal Gentamicin in peritoneal dialysis patients with peritonitis
Scientific title
An observational Study in Optimising Intraperitoneal Gentamicin in peritoneal dialysis patients with peritonitis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gentamicin dosing in Peitonitis in peritoneal dialysis patients 4841 0
Condition category
Condition code
Renal and Urogenital 237184 237184 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patient selection
Patients with clinically defined signs and symptoms of peritonitis who fulfill the inclusion/exclusion criteria below will be eligible for the study.

Two groups of patients will be included with 15 patients entering each group.
a) Anuric patients (with a urine output of less than 100ml/day)
b) Non-anuric patients (with a urine output of more than 100ml/day)

Categorisation of patients into the two groups will be based on data from 24-hour urinary collection done within the preceding 6 months.


Drug dosing
Drug dosing will be based on the current International Society for Peritoneal Dialysis Guidelines (2005).

a) Anuric patients
0.6mg/kg gentamicin in a single bag administered intraperitoneally once daily and allowed to dwell for at least 6 hours for 14 days or 21 days depending on the organism grown in peritoneal dialysis fluid

b) Non-anuric patients
For this group of patients with residual renal function, the dose of gentamicin in group (a) will be increased by 25%


Sample collection
All patients will be sampled on 2 separate days. Serial plasma and peritoneal dialysis (PD) fluid will be collected as follows:

On DAY 1:
Plasma samples (5ml each) taken at 1 hour, 3 hours, 6 hours and 7 hours after the administration of the first bag of gentamicin intraperitoneally.

PD fluid samples (5ml) will also be collected at 3 hours AND at the end of the dwell time.

Between DAY 2 and DAY 5
A plasma sample (5ml) will be taken just prior to the administration of the next bag of gentamicin (to measure ‘trough’ gentamicin levels) followed by plasma samples (5ml each) at 1 hour, 3 hours, 6 hours and 7 hours after the administration of the next bag of gentamicin intraperitoneally.

PD fluid samples (5ml) will also be collected prior to the administration of the next bag of gentamicin, at 3 hours AND at the end of the dwell time.

For each dose of intraperitoneal gentamicin administered, the type and volume of dialysate and inflow rate of the dialysate plus drug will be recorded.

A 5ml sample from the 24 hour urine collection will be collected to measure the concentration of gentamicin excreted in urine. Samples (10ml) from each bag of PD fluid will also be obtained before the dialysis effluent is discarded.
Intervention code [1] 236750 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238002 0
To describe the pharmacokinetics of gentamicin administered intraperitoneally in peritoneal dialysis patients with peritonitis

Sample analysis
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.



Data analysis
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.
Timepoint [1] 238002 0
3 years from baselie
Secondary outcome [1] 242267 0
To develop a pharmacokinetic model that can be used to conduct dosing simulations and to develop dosing recommendations for intraperitoneal gentamicin dosing in peritonitis-
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.
Timepoint [1] 242267 0
3 years from baseline

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-<2 weeks since a course of antibiotics for a previous episode of peritonitis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5000 0
Other Collaborative groups
Name [1] 5000 0
Burns, Critical care and Trauma Research center, University of Queensland
Country [1] 5000 0
Australia
Funding source category [2] 5001 0
Other Collaborative groups
Name [2] 5001 0
Department of Renal Medicine /Royal Brisbane &Women's Hospitals
Country [2] 5001 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Department of Renal Medicine
Address
Level 9,Ned Hanlon Building
Royal Brisbane & Women's Hospitals
Herston Road, Herston, Queensland, 4029
Country
Australia
Secondary sponsor category [1] 4522 0
Charities/Societies/Foundations
Name [1] 4522 0
The Society of Hospital Pharmacists of Australia
Address [1] 4522 0
P O Box 1774, Collingwood 3006, Victoria.
Country [1] 4522 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7103 0
Royal Brisbane &women's Hospitals
Ethics committee address [1] 7103 0
Human Reserach Ethics Committee
Royal Brisbane & Women's Hospitals,
Herston Road, Herston, Queensland, 4029
Ethics committee country [1] 7103 0
Australia
Date submitted for ethics approval [1] 7103 0
12/11/2008
Approval date [1] 7103 0
28/01/2009
Ethics approval number [1] 7103 0
HREC/08/QRBW/8

Summary
Brief summary
The pharmacokinetics of drugs administered intraperitoneally in patients with peritonitis on peritoneal dialysis has not been widely studied. Our main aim will be to maximise efficacy and minimise toxicity of this antibiotic in this group of patients. This project will involve taking serial plasma and peritoneal fluid samples to measure gentamicin concentrations. Sample analysis results will be interpreted using pharmacokinetic computer software to develop dosing guidelines for optimal intraperitoneal dosing of gentamicin for patients with peritonitis undergoing peritoneal dialysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29636 0
Address 29636 0
Country 29636 0
Phone 29636 0
Fax 29636 0
Email 29636 0
Contact person for public queries
Name 12883 0
Dr Dwarakanathan Ranganathan
Address 12883 0
Senior Consultant Nephrologist
Royal Brisbane &women's Hospitals
Herston Road, Herston, 4029, Queensland
Country 12883 0
Australia
Phone 12883 0
+61-7-36368576
Fax 12883 0
+61-7-36368572
Email 12883 0
dwarakanathan_ranganathan@health.qld.gov.au
Contact person for scientific queries
Name 3811 0
Dr Dwarakanathan Ranganathan
Address 3811 0
Senior Consultant Nephrologist
Royal Brisbane &women's Hospitals, Herston Road, Herston, Queensland 4029
Country 3811 0
Australia
Phone 3811 0
+ 61 7-36368576
Fax 3811 0
+ 61 7-36368572
Email 3811 0
dwarakanathan_ranganathan@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePharmacokinetics of intraperitoneal cefalothin and cefazolin in patients being treated for peritoneal dialysis-associated peritonitis.2016https://dx.doi.org/10.3747/pdi.2015.00008
N.B. These documents automatically identified may not have been verified by the study sponsor.