Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001199808
Ethics application status
Approved
Date submitted
17/06/2021
Date registered
8/09/2021
Date last updated
19/10/2023
Date data sharing statement initially provided
8/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a longer length peripheral intravenous catheter on interruptions to intravenous antibiotic delivery in general medical and surgical inpatients: a randomised controlled trial
Scientific title
Does LEngth of peripheral intravenous catheter optimise Antibiotic DelivERy: a pilot randomised controlled trial assessing the impact on interruptions to intravenous antibiotic delivery (The LEADER Study)
Secondary ID [1] 304031 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The LEADER Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter failure prior to completion of antibiotic therapy regime 321661 0
Condition category
Condition code
Infection 319410 319410 0 0
Other infectious diseases
Public Health 319459 319459 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm:
a long-PIVC, i.e. Introcan Safety® Deep Access (B Braun) or BD Insyte™ Autoguard™ BC (long: 4.5-6.4cms length).

Device type, size/gauge and vein selection will be decided by the ReN on assessment of the patient's vascular access. All PIVCs will be inserted, maintained and removed as per hospital policy. All insertions will be performed by a Research Nurse (ReN) experienced in PIVC insertion. PIVCs will be maintained by clinical staff and the decision to remove the PIVC will be made by the treating team. Protocol violations will be participants not receiving the randomised intervention on PIVC insertion.

Protocol adherence will be managed by the ReN who will be responsible for insertion of all study devices and will be described descriptively as per the primary outcomes. Extensive education sessions and written materials will be provided to staff to enhance protocol adherence.

The trial will be conducted in two phases:
Phase One – Pilot Trial
Protocol safety and feasibility will be assessed in a pilot RCT of 70 participants. After 70 patients have been recruited, feasibility outcomes and protocol safety will be assessed. If the interim analysis finds feasibility outcomes are being met and there are no safety issues identified with the protocol, the study will move on to Phase Two. If feasibility outcomes are not being met or safety issues are identified at this point, the study will cease.

Phase Two – Powered RCT
The study will continue recruitment to the final powered sample size calculated as 192 patients (power 0.8) (this will be re-calculated following the interim analysis and adjusted as required).

We will recruit participants over a total of 26 weeks for both phases.
Intervention code [1] 320352 0
Treatment: Devices
Intervention code [2] 321354 0
Prevention
Comparator / control treatment
Control arm:
a short-PIVC, i.e. BD Insyte™ Autoguard™ BC (short less than 4 cms length)

Device size/gauge and vein selection will be decided by the ReN on assessment of the patient's vascular access. All PIVCs will be inserted, maintained and removed as per hospital policy. All insertions will be performed by the ReN experienced in PIVC insertion. PIVCs will be maintained by clinical staff and the decision to remove the PIVC will be made by the treating team. Protocol violations will be participants not receiving the randomised intervention on PIVC insertion.
Control group
Active

Outcomes
Primary outcome [1] 327269 0
Feasibility outcomes will include a composite of the below seven criteria:
i. proportion of those screened who are eligible (greater than 70%);
ii. proportion of those eligible who consent (greater than 90%);
iii. proportion of those who consent who later withdraw or who are lost to follow up (equal to or less than 5%);
iv. proportion who adhere to the randomised protocol (greater than 90%);
v. proportion of missing data (equal to or less than 5%);
vi. proportion of patients satisfied with the study interventions (greater than 80% scoring equal to or greater than 7 on a 0-10 numerical rating scale)
vii. estimates of effect inform a feasible sample size for a larger trial.

For the primary outcome of feasibility, data regarding eligibility and recruitment will be gained from the screening log which will contain 1) all patients screened for study inclusion, regardless of whether they met the eligibility criteria, 2) recruitment status, and 3) treatment allocation. Data for the remaining feasibility outcomes (retention, protocol fidelity, missing data, and patient and staff satisfaction) will be held in the REDCap database and analysed from there.
Timepoint [1] 327269 0
Primary Feasibility Outcome - after 70 patients are recruited.
Primary outcome [2] 327340 0
All-cause post-insertion failure: A composite of infiltration/extravasation, blockage/occlusion (with or without leakage), phlebitis, thrombosis, dislodgement (complete or partial) or infection (laboratory confirmed local or bloodstream infection). This composite measure incorporates the multifocal path to the same endpoint; PIVC failure resulting in premature device removal before the end of intravenous therapy.

This information will be collected by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [2] 327340 0
Assessed following PIVC insertion and commencement of antibiotic delivery all patients will be assessed daily Monday to Friday until 48 hours after the device is removed.
Secondary outcome [1] 394400 0
Number of IV devices inserted per patient to complete the course of antibiotics (randomised and any subsequent short-PIVC, long-PIVC, midline catheters or Central Venous Access Device (CVAD)).

This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [1] 394400 0
Assessed daily Monday to Friday while allocated PIVC is insitu and then second daily Monday to Friday after allocated PIVC removal until either discharge; insertion of CVAD; or 24 hours with no device and no planned IVAB therapy.
Secondary outcome [2] 394401 0
Type of IV devices inserted per patient to complete the course of antibiotics (randomised and any subsequent short-PIVC, long-PIVC, midline catheters or Central Venous Access Device (CVAD)).
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [2] 394401 0
Assessed daily Monday to Friday while allocated PIVC is insitu and then second daily Monday to Friday after allocated PIVC removal until either discharge; insertion of CVAD; or 24 hours with no device and no planned IVAB therapy.
Secondary outcome [3] 399290 0
Dwell time of IV devices inserted per patient to complete the course of antibiotics (randomised and any subsequent short-PIVC, long-PIVC, midline catheters or Central Venous Access Device (CVAD)).
This information will be collected by the research nurse from either direct observation, consultation with the clinical staff or review of medical record.
Timepoint [3] 399290 0
Assessed daily Monday to Friday while allocated PIVC is insitu and then second daily Monday to Friday after allocated PIVC removal until either discharge; insertion of CVAD; or 24 hours with no device and no planned IVAB therapy.
Secondary outcome [4] 399291 0
Overall insertion success (yes/no).

This data will be self-reported by the Research Nurse for the allocated device. Subsequent device data will be assessed by the Research Nurse during daily checks; patient-reported or identified on review of the patient's medical record.
Timepoint [4] 399291 0
Assessed at insertion of allocated PIVC and then second daily Monday to Friday after allocated PIVC removal until either discharge; insertion of CVAD; or 24 hours with no device and no planned IVAB therapy.
Secondary outcome [5] 400475 0
Number of PIVCs that are unable to be successfully inserted.

This data will be self-reported by the Research Nurse for the allocated device. Subsequent device data will be assessed by the Research Nurse during daily checks; patient-reported or identified on review of the patient's medical record.
Timepoint [5] 400475 0
Assessed at insertion of allocated PIVC and then second daily Monday to Friday after allocated PIVC removal until either discharge; insertion of CVAD; or 24 hours with no device and no planned IVAB therapy.
Secondary outcome [6] 400476 0
Number of insertion attempts (needle punctures) required to insert the device.

This data will be self-reported by the Research Nurse.
Timepoint [6] 400476 0
From the time of randomisation until 24 hours post-randomisation.
Secondary outcome [7] 400477 0
Highest patient reported pain, resulting from insertion attempts (0-10 verbal rating scale).
Timepoint [7] 400477 0
From the time of randomisation until 24 hours post-randomisation.
Secondary outcome [8] 400478 0
Laboratory Confirmed Bloodstream Infection as defined by NHSN 2021 criteria.

This information will be assessed by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of medical record, AUSLAB or AUSCARE results.
Timepoint [8] 400478 0
Assessed daily Monday to Friday while allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [9] 400479 0
Localised peripheral IV site infection (without bloodstream infection) as per NHSN 2021 CVS-VASC criteria.

This information will be assessed by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of medical record, AUSLAB or AUSCARE results.
Timepoint [9] 400479 0
Assessed daily Monday to Friday while allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [10] 400480 0
Phlebitis: Defined as 2 or more signs/symptoms of: pain/tenderness (score greater than 2/10); redness; swelling; or palpable cord/vein streak from the entry site.

This information will be collected by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [10] 400480 0
Assessed daily Monday to Friday while allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [11] 400481 0
Occlusion/blockage (with/without leakage) defined as: PIVC will not infuse or flush or leakage occurs when fluids infused/flushed.

This information will be collected by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [11] 400481 0
Assessed daily Monday to Friday while allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [12] 400482 0
Infiltration/Extravasation: Defined as the movement of IV fluid/vesicant into surrounding tissue, with or without resulting tissue damage.

This information will be collected by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [12] 400482 0
Assessed daily Monday to Friday while allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [13] 400483 0
Thrombosis (either suspected on confirmed):
Suspected - as assessed/suspected by the treating clinician.
Confirmed - ultrasound/venographic confirmed thrombosed vessel at the device site.

This will be assessed by a review of the patient's medical records (including ultrasound findings).
Timepoint [13] 400483 0
Assessed daily Monday to Friday while allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [14] 400484 0
Dislodgement (partial/complete) defined as:
Partial - change in device length at insertion site (catheter tubing visible).
Total - device completely leaves the vein.

This information will be collected by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [14] 400484 0
Assessed daily Monday to Friday while allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [15] 400485 0
Adverse events (eg. Nerve damage, Extravasation injury, PIVC related BSI or skin events).

Nerve damage as diagnosed by the treating clinical team and documented in the patient's medical record.

Extravasation injury as previously defined.

PIVC related blood stream infection as previously defined.

Skin event (skin tear, dermatitis, blister) as identified by the ReN or treating clinical team and documented in the patient's medical record.

This information will be collected by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of the medical record.
Timepoint [15] 400485 0
Assessed daily Monday to Friday while the allocated PIVC is insitu until 48 hours post device removal.
Secondary outcome [16] 400486 0
Patient reported satisfaction of PIVC insertion measured on a Visual Analogue Scale (0-10).
Timepoint [16] 400486 0
From the time of randomisation until the time of device insertion.
Secondary outcome [17] 400487 0
Patient reported satisfaction of PIVC removal measured on a Visual Analogue Scale (0-10).
Timepoint [17] 400487 0
From device removal to 48 hours post-removal
Secondary outcome [18] 400488 0
Patient reported overall satisfaction with the PIVC device for the duration the device is insitu measured on a Visual Analogue Scale (0-10).
Timepoint [18] 400488 0
From duration device is insitu until device removal up to 48 hours post-removal.
Secondary outcome [19] 400489 0
Cost estimate (subset of 7 participants per study arm), including costs of treating any PIVC reinsertion and PIVC-related complications.

This will be collected at the completion of the study from information in our existing data set.
Timepoint [19] 400489 0
From insertion of allocated PIVC until study removal at the convenience of the research staff.

Eligibility
Key inclusion criteria
• 18 years or older
• Requiring peripherally-compatible IV antibiotic treatment for equal to or greater than 3
days
• ability to provide informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with upper arm limitations (e.g. mastectomy, renal patients)
• Non-English-speaking patients without interpreter
• Patient receiving end-of-life care
• Previous enrolment in the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed until time of web-based central randomisation service. Participants will be randomised after consenting to participate, just prior to PIVC insertion. Once the patient is randomised the treatment allocation will be revealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated in a ratio of 1:1 (control to intervention) with randomly varied permuted block sizes of 4 and 6.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Trial feasibility outcomes will be reported descriptively and compared against the a priori acceptability limits (there is no expectation that statistically significant results will be found in the clinical outcomes during the feasibility phase).
All randomised patients will be analysed by intention to treat with the exception of a small number anticipated to have device insertion/IV antibiotic therapy cancelled prior to any procedure being attempted.
The primary outcome of antibiotic interruption (time-to-event variable) will be examined using incidence rates with 95% confidence intervals and Cox proportional hazards regression, with group (short-PIVC, long-PIVC) included as the main effect. If the proportional hazards assumption does not hold, the groups will be compared using the log-rank test. Kaplan-Meier survival curves will be used to display failure curves for each group.
Other secondary clinical outcomes will be compared between groups with appropriate parametric or non-parametric techniques. Cost analysis will be reported descriptively.
Continuous data will be reported as means (standard deviation) or median (interquartile limits), dependant on normality testing. P values <0·05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/09/2021
Date of last participant enrolment
Anticipated
6/09/2022
Actual
15/02/2023
Date of last data collection
Anticipated
6/10/2022
Actual
9/03/2023
Sample size
Target
192
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19214 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 33786 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 308413 0
Hospital
Name [1] 308413 0
Royal Brisbane and Women's Hospital
Country [1] 308413 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Ms Amanda Corley
Nursing and Midwifery Research Centre
Level 2, Centre for Clinical Nursing, Building 34
Royal Brisbane and Women’s Hospital
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 310584 0
None
Name [1] 310584 0
.
Address [1] 310584 0
.
Country [1] 310584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308375 0
Royal Brisbane and Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 308375 0
Ethics committee country [1] 308375 0
Australia
Date submitted for ethics approval [1] 308375 0
27/04/2021
Approval date [1] 308375 0
09/06/2021
Ethics approval number [1] 308375 0
HREC/2021/QRBW/75234

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

Contacts
Principal investigator
Name 110490 0
Ms Amanda Corley
Address 110490 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 110490 0
Australia
Phone 110490 0
+61 7 3646 8725
Fax 110490 0
N/A
Email 110490 0
[email protected]
Contact person for public queries
Name 110491 0
Amanda Corley
Address 110491 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 110491 0
Australia
Phone 110491 0
+61 7 3646 8725
Fax 110491 0
N/A
Email 110491 0
[email protected]
Contact person for scientific queries
Name 110492 0
Amanda Corley
Address 110492 0
Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 110492 0
Australia
Phone 110492 0
+61 7 3646 8725
Fax 110492 0
N/A
Email 110492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Chief Investigator
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
Access subject to approvals by Chief Investigator.
[email protected]


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.