ANZCTR - Registration

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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

Condition category

Condition code

Renal and Urogenital

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

3 years from baselie

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Burns, Critical care and Trauma Research center, University of Queensland

Address [1]

Herston Road, Herston, Queensland, 4029

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Department of Renal Medicine /Royal Brisbane &Women's Hospitals

Address [2]

Herston Road, Herston, Queensland, 4029

Country [2]

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]

Charities/Societies/Foundations

Name [1]

The Society of Hospital Pharmacists of Australia

Address [1]

P O Box 1774, Collingwood 3006, Victoria.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane &women's Hospitals

Ethics committee address [1]

Human Reserach Ethics Committee
Royal Brisbane & Women's Hospitals,
Herston Road, Herston, Queensland, 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/11/2008

Approval date [1]

28/01/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Dwarakanathan Ranganathan

Address

Senior Consultant Nephrologist
Royal Brisbane &women's Hospitals
Herston Road, Herston, 4029, Queensland

Country

Australia

Phone

+61-7-36368576

Fax

+61-7-36368572

[email protected]

Contact person for scientific queries

Name

Dr Dwarakanathan Ranganathan

Address

Senior Consultant Nephrologist
Royal Brisbane &women's Hospitals, Herston Road, Herston, Queensland 4029

Country

Australia

Phone

+ 61 7-36368576

Fax

+ 61 7-36368572

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	Pharmacokinetics of intraperitoneal cefalothin and cefazolin in patients being treated for peritoneal dialysis-associated peritonitis.	2016	https://dx.doi.org/10.3747/pdi.2015.00008

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically