Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000078459
Ethics application status
Approved
Date submitted
19/01/2016
Date registered
25/01/2016
Date last updated
10/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of haemodiafiltration on the pharmacokinetics of potent antibiotics.
Scientific title
Impact of haemodiafiltration on the pharmacokinetics of potent antibiotics, Meropenem and Tazociin.
Secondary ID [1] 288358 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 297350 0
Condition category
Condition code
Renal and Urogenital 297543 297543 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pharmacokinetic study relates to a single HDF session, where the antibiotic (meropenem or tazocin) will be administered intravenously at 30 minutes prior to the start of the dialysis session. Basline bloods are taken. The anitbiotic is administered followed by a 15 and 30 minute sample. The dialysis session is then started and samples are then taken (15 min, 30 min, 60 min, 2 hours and 4 hours) to measure antibiotic concentrations over time during the 4 hour dialysis session followed by a post dialysis sample 1 hour after completion..
Dose of Meropenem is 1gm IV (session 1)
Dose of tazocin 4.5gms IV (session 2).
Each participant will undergo 2 pharmacokinetic clearance studies on HDF. One for meropenem pharmacokinetics and one for Tazocin pharmacokinetics These studies will be separated by at least a week.
Intervention code [1] 293663 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297098 0
Determination of pharmacokinetics of meropenem or tazocin for stable haemodialysis patients during a single session of haemodiafiltration.
The pharmacokinetics of these drugs during a HDF session will be estimated using a population pharmacokinetic approach with the standard software NONMEM (ver 7.2.0).
Cmax, Tmax, AUC and clearances will all be measured.
Timepoint [1] 297098 0
Timed sampling across a dialysis session.
Baseline pre-antibiotic dose, then at 15min,prior to commencement of HDF.
Following commencement of HDF, blood samples will be collected at 15 min, 30 min, 45 min, 60 min, 2hours, and 4hours (completion of HDF session and a final sample 1 hour post HDF.
Blood samples wil be taken before and after dialysis membrane.
Dialysate samples: baseline, 30 mins, 60 mins, 2 hours, 4 hours.
Secondary outcome [1] 320019 0
None
Timepoint [1] 320019 0
None

Eligibility
Key inclusion criteria
Stable haemodialysis patients aged from 18 - 75 years.
able to give informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give consent.
Known penicillin allergy or previous allergy to meropenem or tazocin.
An intercurrent infection requiring antibiotic therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
There is no data on the pharmacokinetics of meropenem or tazocin for patients on haemodiafiltration, so a power calculation is not appropriate. with the multiple blood sampling.
6 participants will provide sufficient pharmacokinetic data to undertake modeling.using a population pharmacokinetic approach with the standard software NONMEM (ver 7.2.0).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2016
Actual
31/05/2016
Date of last participant enrolment
Anticipated
30/12/2016
Actual
10/10/2016
Date of last data collection
Anticipated
Actual
11/10/2016
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 7539 0
New Zealand
State/province [1] 7539 0
Otago

Funding & Sponsors
Funding source category [1] 292714 0
Charities/Societies/Foundations
Name [1] 292714 0
Otago Medical Reserch Foundation
Country [1] 292714 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
PO Box 56 Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 291447 0
None
Name [1] 291447 0
Address [1] 291447 0
Country [1] 291447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294199 0
Health and Disability Ethics Committee
Ethics committee address [1] 294199 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 294199 0
New Zealand
Date submitted for ethics approval [1] 294199 0
25/01/2016
Approval date [1] 294199 0
09/02/2016
Ethics approval number [1] 294199 0
Study number: 16 / STH/ 9

Summary
Brief summary
This study aims to investigate how quickly two potent anitbiotics used to treat septic patients in the ICU are removed by haemodiafiltration (HDF). Septic patients often have acute kidney injury and require HDF support to maintain kidney function. We do not know how well antibiotics are removed by HDF and therefore do not have appropriate dosing guidelines to ensure adequate therapeutic concentrations of the antibiotic is maintained. This study will measure the changes in antibiotic concentrations over a HDF session. The results will enable us to more accurately recommend the correct dose and timing for the dose for septic patients with acute kidney injury.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 62870 0
Prof Robert Walker
Address 62870 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 62870 0
New Zealand
Phone 62870 0
+64 3 4740999
Fax 62870 0
+64 3 4747641
Email 62870 0
rob.walker@otago.ac.nz
Contact person for public queries
Name 62871 0
Robert Walker
Address 62871 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 62871 0
New Zealand
Phone 62871 0
+64 3 4740999
Fax 62871 0
+64 3 4747641
Email 62871 0
rob.walker@otago.ac.nz
Contact person for scientific queries
Name 62872 0
Robert Walker
Address 62872 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 62872 0
New Zealand
Phone 62872 0
+64 3 474 0999
Fax 62872 0
+64 3 4747641
Email 62872 0
rob.walker@otago.ac.nz

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
EmbaseThe pharmacokinetics of meropenem and piperacillin-tazobactam during sustained low efficiency haemodiafiltration (SLED-HDF).2020https://dx.doi.org/10.1007/s00228-019-02792-0
N.B. These documents automatically identified may not have been verified by the study sponsor.