Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000052437p
Ethics application status
Submitted, not yet approved
Date submitted
11/09/2015
Date registered
20/01/2016
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of potent antibiotics with Sustained Low Efficiency Dialysis in Intensive Care.
Scientific title
Pharmacokinetics of meropenem and tazocin in septic patients requiring slow efficiency dialysis (SLED) with haemodiafiltration (HDF).
Secondary ID [1] 287458 0
None
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 296181 0
Sepsis 297349 0
Condition category
Condition code
Infection 296458 296458 0 0
Other infectious diseases
Renal and Urogenital 296459 296459 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Open label pharmacokinetic study of meropenem and tazocin in septic patients requiring slow low efficiency dialysis (SLED) with haemodiafiltration (HDF).
Both the dialysis therapy and antibiotic therapy will be administered regardless of enrolment.
The pharmacokinetic study relates to a single SLED-HDF session, where the antibiotic (meropenem or tazocin) has been administered intravenously prior to the start of the dialysis session. Samples are then taken to measure antibiotic concentrations over time during the dialysis session. Where possble the pharmacokinetic study will be repeated during the next dialysis session which may be 24 or 48 hours later, depending upon the patient's clinicall status.
Intervention code [1] 292831 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296083 0
Determination of pharmacokinetics of meropenem or tazocin for septic patients requiring SLED-HDF for the treatment of their acute kidney injury.
The pharmacokinetics of these drugs on SLED-HDF will be estimated using a population pharmacokinetic approach with the standard software NONMEM (ver 7.2.0).
Timepoint [1] 296083 0
Timed sampling across a dialysis session.
Baseline pre-antibiotic dose, then at 15min, 30min, 60 min, 2hours post antibiotic but pre-SLED-HDF.
Commencement SLED-HDF. Blood samples at 15 min, 30 min, 45 min, 60 min, 2hours, 4hours and 6 hours and then immediately prior to next dose.
Blood samples wil be taken before and after dialysis membrane.
Dialysate samples: baseline, 30 mins, 60 mins, 2 hours, 4 hours, 6 hours.
Urine samples (if not anuric). Baseline, 0-2hours (predialysis). 0-2 hours on dialysis, 2 - 6 hours on dialysis (before next dose of antibiotic).
Each participant will undergo 2 pharmacokinetic clearance studies on SLED-HDF. These will be separated by at least 24 – 48 hours as SLED-HDF is usually scheduled on alternate days.
Secondary outcome [1] 318325 0
None
Timepoint [1] 318325 0
None

Eligibility
Key inclusion criteria
Any septic ICU patient, treated with meropenem or tazocin who requires SLED-HDF for the treatment of their acute kidney injury
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The next of kin do not consent to particpation. (Rarely will the individual be able to give consent as they will be ventilated and sedated).
Intensivist deem the participant is not suitable for the study on clinical grounds.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
There is no data on the pharmacokinetics of meropenem or tazocin for patients on SLED-HDF, so a power calculation is not appropriate. By repeating the clearance studies for each patient twice, we assume that with 5-6 participants we will have sufficient data to undertake the pharmacokinetic modeling.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study not approved by ethics due to new Crown Law ruling on studies in ICU
Date of first participant enrolment
Anticipated
4/07/2016
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 7159 0
New Zealand
State/province [1] 7159 0
Otago

Funding & Sponsors
Funding source category [1] 292029 0
Charities/Societies/Foundations
Name [1] 292029 0
Application to Otago Medical Research Foundation currently being submitted
Country [1] 292029 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] 290700 0
Other Collaborative groups
Name [1] 290700 0
Health Research South
Address [1] 290700 0
SDHB
Private Bag 1970
Dunedin 9054
Country [1] 290700 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293516 0
Health and Disability Ethics Committee NZ
Ethics committee address [1] 293516 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 293516 0
New Zealand
Date submitted for ethics approval [1] 293516 0
21/09/2015
Approval date [1] 293516 0
Ethics approval number [1] 293516 0

Summary
Brief summary
This study aims to investigate how quickly two potent anitbiotics used to treat septic patients in the ICU are removed by dialysis. Septic patients often have acute kidney injury and require dialysis support to maintain kidney function. We do not know how well antibiotics are removed by dialysis 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 dialysis 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
Do not have one.
Trial related presentations / publications
None at present
Public notes
None at present

Contacts
Principal investigator
Name 60262 0
Prof Robert Walker
Address 60262 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 60262 0
New Zealand
Phone 60262 0
+64 3 4740999
Fax 60262 0
+64 3 474 7641
Email 60262 0
[email protected]
Contact person for public queries
Name 60263 0
Prof Robert Walker
Address 60263 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 60263 0
New Zealand
Phone 60263 0
+64 3 4740999
Fax 60263 0
+64 3 4747641
Email 60263 0
[email protected]
Contact person for scientific queries
Name 60264 0
Prof Robert Walker
Address 60264 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 60264 0
New Zealand
Phone 60264 0
+64 3 4740999
Fax 60264 0
+64 3 4747641
Email 60264 0
[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
No additional documents have been identified.