Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000089134
Ethics application status
Approved
Date submitted
18/01/2019
Date registered
22/01/2019
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of elastomeric infusors as an alternative method of delivering continuous infusions of antibiotics via peripheral cannula for hospital in the home patients.
Scientific title
The effectiveness of elastomeric infusors as an alternative method of delivering continuous infusions of antibiotics via peripheral cannula for hospital in the home patients
Secondary ID [1] 297131 0
None
Universal Trial Number (UTN)
None
Trial acronym
EPIC-HITH
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Intravenous antibiotic administration 311160 0
Condition category
Condition code
Public Health 309781 309781 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this project is to provide evidence for an alternative administration method for short term continuous intravenous (IV) antibiotic infusions in patients with only peripherally inserted venous cannula (PIVC) access.

This research will be conducted as a randomized controlled trial.
(Intervention) Study device A: Baxter LV10 elastomeric infusor
(Control) Study device B: CADD-Solis 2120 programmable infusion pump

The Baxter LV10 elastomeric infusor are an infusion device that can be worn on the body that delivers antibiotic using a balloon-like drug reservoir filled under pressure. They are designed to hold 240mL of infusant and deliver this at a set rate of 10ml/hour when connected to the venous cannula. This device is non-electronic, light weight, silent to operate and relatively cheap to purchase per device.
The CADD-Solis 2120 is a battery-operated infusion pump that can be worn on the body and requires programming by a trained clinician to deliver an infusion at the desired infusion rate. This device features built-in safety checks and alerts, however the pumps are expensive to purchase and are not as light at the Baxter infusor and is not always appropriate for young children or persons with mobility issues.
Patient's referred to HITH for short term (<14 days planned) of intravenous antibiotics who meet all the inclusion criteria and none of the exclusion criteria will be consented to participate in this study. Participants will be randomised to receive their antibiotic treatment course by either study device A or study device B for the duration of treatment unless withdrawn from the study. Participants receive instructional materials regarding the appropriate management of designated device in the home including trouble-shooting guide and contact numbers for assistance if required. These materials are standard of care for all patients on the HITH program, written and supplied by Bundaberg HITH service with exception of the Baxter infusor guide pamphlets, designed by Baxter Healthcare. 24hr support provided by Hospital in the Home clinical nurses is available for all study participants in line with routine HITH patient care.
Trained clinical nursing staff are responsible for seeing participants daily as part of the Hospital In The Home usual care but will in addition perform the recording of pre-infusion and post-infusion data (device weight and time connected, then the device weight and time disconnected) for each infusion device used by each patient, and changing over the infusion every 22-24 hours.
Intervention code [1] 313395 0
Treatment: Devices
Comparator / control treatment
Study device B: CADD-Solis 2120 programmable infusion pump is the standard infusion pump used by the Hospital In The Home service to deliver infusions via the peripheral cannula.
Control group
Active

Outcomes
Primary outcome [1] 318738 0
The proportion of Baxter LV10 elastomeric infusors and CADD-Solis 2120 programmable pump infusion episodes that deliver at least 90% of the antibiotic infusant, as determined by weighing each infusion on scientific scales (Ohaus NV1100 balance) before starting the infusion and again after at least 22 hours of infusion, via the peripheral cannula.
Timepoint [1] 318738 0
Over the duration of the patients prescribed antibiotic course between 1 - 14 days.
Secondary outcome [1] 365863 0
The proportion of Baxter LV10 elastomeric infusors and CADD-solis 2120 programmable pumps that experience an adverse event or fail to infuse due to a un-intentional interruption to the infusion secondary to an infusion line blockage, device failure or cannula extravasation/blockage, as determined a the time of incident by clinical examination by the attending clinical nurse or medical officer.
Timepoint [1] 365863 0
At any point during a patients treatment course between 1-14 days.
Secondary outcome [2] 365864 0
The cost and potential financial benefit of using Baxter LV10 elastomeric infusors paired with venous access, compared with the CADD-solis 2120 programmable pump as calculated by using Bundaberg hospital purchasing records to determine cost per infusion.
Timepoint [2] 365864 0
On a daily basis over the course of the participants treatment duration

Eligibility
Key inclusion criteria
Patient meets hospital in the home program eligibility
IV antibiotic is suitable for continuous infusion via the peripheral cannula: cefazolin, lincomycin, piperacillin-tazobactam
Expected IV antibiotic course is less than 14 days
A peripheral cannula can be placed in the patients forearm
Aged 18yrs or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Difficult venous access expected
Patient is not able to follow infusion device instructions
Patient has suitable central venous access device in situ

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central generation via phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Goal is to collect 100 infusion data sets from each study arm device.
Chi-squared will be used to determine if their is a difference between the two devices infusion delivery according to the defined limit of at least 90% being infused over each 22-24hr period.
Secondary outcomes will be reported descriptively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/07/2017
Date of last participant enrolment
Anticipated
Actual
14/12/2018
Date of last data collection
Anticipated
Actual
17/12/2018
Sample size
Target
200
Accrual to date
Final
203
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12959 0
Bundaberg Hospital - Bundaberg
Recruitment postcode(s) [1] 25431 0
4670 - Bundaberg

Funding & Sponsors
Funding source category [1] 301692 0
Hospital
Name [1] 301692 0
Bundaberg Hospital
Country [1] 301692 0
Australia
Primary sponsor type
University
Name
Monash University
Address
381 Royal Parade
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 301415 0
None
Name [1] 301415 0
Address [1] 301415 0
Country [1] 301415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302412 0
Royal Brisbane & Womens Hospital Human Research Ethics Commitee
Ethics committee address [1] 302412 0
Ethics committee country [1] 302412 0
Australia
Date submitted for ethics approval [1] 302412 0
27/01/2017
Approval date [1] 302412 0
13/03/2017
Ethics approval number [1] 302412 0
HREC/17/QRBW/110

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90154 0
Ms Tracey Watson
Address 90154 0
Pharmacy Department, Bundaberg Hospital
271 Bourbong Street
Bundaberg Queensland 4670
Country 90154 0
Australia
Phone 90154 0
+61 0741502851
Fax 90154 0
Email 90154 0
[email protected]
Contact person for public queries
Name 90155 0
Tracey Watson
Address 90155 0
Pharmacy Department, Bundaberg Hospital
271 Bourbong Street
Bundaberg Queensland 4670
Country 90155 0
Australia
Phone 90155 0
+61 0741502851
Fax 90155 0
Email 90155 0
[email protected]
Contact person for scientific queries
Name 90156 0
Tracey Watson
Address 90156 0
Pharmacy Department, Bundaberg Hospital
271 Bourbong Street
Bundaberg Queensland 4670
Country 90156 0
Australia
Phone 90156 0
+61 0741502851
Fax 90156 0
Email 90156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD is not relevant as this study is examining study device data collectively, not individual participants.


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.