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Trial registered on ANZCTR


Registration number
ACTRN12615000977572
Ethics application status
Approved
Date submitted
28/08/2015
Date registered
18/09/2015
Date last updated
28/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The dressing and securement of non-tunnelled Central Venous Access Devices (CVADs), in the paediatric intensive care: a pilot, randomised controlled trial.
Scientific title
Randomised controlled trial of tissue adhesive, combined securement and dressing product versus standard care (bordered polyurethane) dressings to prevent central venous access device failure in paediatric intensive care patients with non-tunnelled
central venous access devices: the CASCADE Junior PICU trial.
Secondary ID [1] 287355 0
Nil
Universal Trial Number (UTN)
U1111-1173-6689
Trial acronym
The CASCADE PICU Junior
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device complication and failure prior to completion of therapy
296015 0
Condition category
Condition code
Public Health 296295 296295 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have central venous access devices (CVADs) used in to assist treatment while they are admitted to the paediatric intensive care unit. Consenting parents or legal guardians, andpatients (if appropriate) will have their non- tunnelled CVADs secured with one of the following randomly assigned dressings and securements:

Arm 1: Tissue Adhesive (TA) is a medical grade 'superglue'
(cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing, prolene suture and a chlorhexidine-impregnated disc will also be applied.

Arm 2: Integrated dressing - securement product: extra-reinforced borders, with an absorbent layer around the polyurethane claimedto ‘wick’ moisture away from the wound. This will be used in addition to prolene suture and a chlorhexidine-impregnated disc.

Arm 3 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They will also have their CVAD secured with prolene sutures and a chlorhexidine-impregnated disc.

The randomly allocated dressing will be applied until completion of therapy, hospital discharge or at 4 weeks. The dressing will be applied at CVAD insertion and then changed every 7 days, or on disruption of the dressing integrity.
Intervention code [1] 292691 0
Prevention
Intervention code [2] 292692 0
Treatment: Devices
Comparator / control treatment
Arm 3 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They will also have their CVAD secured with prolene sutures and a chlorhexidine-impregnated disc.
Control group
Active

Outcomes
Primary outcome [1] 295949 0
CVAD failure: Cessation of function prior to completion of therapy assessed by review of hospital records
Timepoint [1] 295949 0
CVAD removal, 4 weeks or hospital discharge assessed by review of hospital records
Primary outcome [2] 295950 0
Feasibility of a full efficacy trial as established by:
*Eligibility: Percentage of patients screened that are eligible;
*Recruitment: Percentage of eligible patients who agree to enrol;
*Retention and attrition: Percentage of participants who are lost to followup or withdraw from study;
*Protocol adherence: Percentage of participants who receive their
allocated treatment throughout their study participation;
*Missing data: Percentage of data missed during study data collection;
*Parent and healthcare staff satisfaction and acceptability: Using a semi-structured survey; and
*Sample size estimates: a reduction in all-cause CVAD failure or complication (by at least 5% in the experimental arms, in
comparison to standard care)
Timepoint [2] 295950 0
At study conclusion assessed by review of study documents
Primary outcome [3] 296041 0
CVAD complication: A composite of CABSI, local infection, occlusion, dislodgement, venous thrombosis or breakage (assessment criteria and definitions in secondary outcomes)
Timepoint [3] 296041 0
CVAD removal, 4 weeks or hospital discharge, assessed by review of hospital records
Secondary outcome [1] 316999 0
Catheter-associated bloodstream infection (CABSI):
A laboratory-confirmed bloodstream infection (LCBI) in a patient who had a central line within the 48 hour period before the development of the BSI, and that is not related to an infection at another site. The CLABSI must meet one of the following criteria of LCBI: Criterion 1: Patient has a recognised pathogen cultured from one or more blood cultures and Organism cultured from blood is not related to an infection at another site. OR Criterion 2: Patient has at least one of the following signs or symptoms: fever (greater than 38 degrees C), chills, or hypotension, and signs and symptoms and positive laboratory results are not related to an infection at another site, and common skin contaminant* is cultured from two or more blood cultures drawn on separate occasions. Examples of common skin contaminants: diphtheroids [Corynebacterium spp.], Bacillus [not B. anthracis] spp., Propionibacterium spp., coagulasenegative staphylococci [including S. epidermidis], viridans group streptococci, Aerococcus spp., Micrococcus spp. Determined by blinded infectious disease specialist
Timepoint [1] 316999 0
CVAD removal, 4 weeks or hospital discharge.
Secondary outcome [2] 317000 0
Local infection: Purulent discharge, or redness extending 1cm beyond the site that prompts clinician to order removal, or commence antimicrobial therapy. Determined by treating physician
Timepoint [2] 317000 0
CVAD removal, 4 weeks or hospital discharge.
Secondary outcome [3] 317001 0
Venous thrombosis: Development of thrombosed vessel (partial or complete) at the CVAD site diagnosed radiologically as requested by the treating clinician in a symptomatic patient
Timepoint [3] 317001 0
CVAD removal, 4 weeks or hospital discharge
Secondary outcome [4] 317002 0
Dislodgement: Partial –change in CVAD length from hub to tip, as measured by marking closest to hub, or CVAD removal because tip is no longer in superior or inferior vena cava (diagnosed by xray/leakage from site on injection/infusion). Complete: CVAD body completely leaves the vein. Determined by treating clinician.
Timepoint [4] 317002 0
CVAD removal, 4 weeks or hospital discharge
Secondary outcome [5] 317003 0
Occlusion: Partial: 1 lumens cannot be flushed and/or aspirated, or resolved after anticoagulant dwell. Complete: all lumens cannot be flushed and/or aspirated despite anticoagulant dwell. Determined by treating physician.
Timepoint [5] 317003 0
CVAD removal, 4 weeks or hospital discharge
Secondary outcome [6] 317004 0
CVAD breakage: Visible split in CVAD material diagnosed by leakage or radiographic evidence of extravasation from a portion of the CVAD into tissue. Determined by treating clinician.
Timepoint [6] 317004 0
CVAD removal, 4 weeks or hospital discharge
Secondary outcome [7] 317005 0
CVAD-related BSI: Laboratory confirmed with matched organism from blood and catheter tip culture
Timepoint [7] 317005 0
CVAD removal, 4 weeks or hospital discharge
Secondary outcome [8] 317006 0
Securement-dressing failure: Replacement in under seven days for loose, missing, bloodstained, diaphoresis or secretion soaked dressings. As assessed by review of hospital notes.
Timepoint [8] 317006 0
CVAD removal, 4 weeks or hospital discharge
Secondary outcome [9] 317007 0
CVAD and first securement-dressing dwell period: Days from insertion/application of CVAD/dressing until removal. As assessed by review of hospital notes.
Timepoint [9] 317007 0
CVAD removal, 4 weeks or hospital discharge
Secondary outcome [10] 317008 0
Cost effectiveness: Estimates of direct product costs, healthcare resource utilisation (including additional equipment, staff time) and failure-associated resource usage using previously established cost estimates
Timepoint [10] 317008 0
Study completion
Secondary outcome [11] 317009 0
Safety: Skin complications including skin rash, skin tears, blisters, pruritis, local or systemic allergic reaction. As assessed by treating clinician.
Timepoint [11] 317009 0
CVAD removal, 4 weeks or hospital discharge

Eligibility
Key inclusion criteria
*Patients < 18 years of age
*Will remain admitted to the Lady Cilento Children’s Hospital for >24 hours
*Informed consent to participate
*Non-tunnelled CVAD to be inserted and will remain insitu for >24 hours
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*All other intravascular device types (e.g. peripherally inserted central catheters, totally implanted CVADs, peripheral intravascular devices)
*Current bloodstream infection
*Non-English speakers without an interpreter
*CVADs inserted through diseased burned or scarred skin
*Known allergy to any study product
*Current skin tear / ‘papery’ skin at high risk of tear
*Previous enrolment in the study within this hospital admission

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)
The research nurse (ReN) will screen patients daily (screening log kept), gain informed consent, and perform randomisation. The ReN will have the study products in pre-packs and liaise closely with the ordering and inserting intensivist or anaesthetist. All eligible patients (or their representative) will be approached for written informed consent by the ReN or inserter. If this is given, the staff member use a centralised web-based randomisation service. Allocation is fully concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Randomisation will be in a 1:1:1 ratio between the three study groups. Permuted blocks in randomly varied sizes will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All randomised patients will be analysed by intention to treat, regardless of treatment received. The patient is the unit of measurement with one CVAD per patient.
Feasibility outcomes will be described using descriptive statistics
including mean, median, range, IQR, counts and percentages.
Comparability of groups at baseline will be assessed using clinical parameters. Relative incidence rates of CVAD failure and complication per 100 devices and per 1,000 device days with 95% confidence intervals (CIs) will summarise the impact of each dressing, and to test difference between groups. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare CVAD failure and complication over time. Secondary
endpoints including CVAD dwell-time, costs, dislodgement, occlusion, CVAD breakage, patient/staff satisfaction scores and adverse events will be compared between groups using parametric/nonparametric techniques as appropriate. Data will be exported into PASW 22.0 (SPSS Inc, Chicago, IL). Prior to analysis, data cleaning of outlying figures, missing, and implausible data will be undertaken, and a random 5% sample of source data rechecked. All attempts will be made to collect the primary endpoint. Missing data will be modelled for best- and worst-case outcomes to assess for effect on overall results. A per-protocol analysis will assess the effect of protocol
violations. P values of <0.05 will be considered significant.

Sample size and study power: This is a pilot study to gain information to prepare for an efficacy trial. Sixty participants per study arm will be recruited - totaling 180 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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)
QLD
Recruitment hospital [1] 4268 0
Lady Cilento Children's Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 291913 0
University
Name [1] 291913 0
Griffith University
Address [1] 291913 0
Nathan Campus,
170 Kessels Road,
Nathan, QLD 4111
Country [1] 291913 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road,
Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 290581 0
None
Name [1] 290581 0
Address [1] 290581 0
Country [1] 290581 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293419 0
Children's Health Services, Queensland
Ethics committee address [1] 293419 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street
SOUTH BRISBANE QLD 4101
Ethics committee country [1] 293419 0
Australia
Date submitted for ethics approval [1] 293419 0
Approval date [1] 293419 0
14/11/2013
Ethics approval number [1] 293419 0
HREC/13/QRCH/181

Summary
Brief summary
Children admitted to the paediatric intensive care unit frequently require the insertion of a CVAD for the administration of medication and fluids. These CVADs are associated with a high rate of failure, including CVAD-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU) and chlorhexidine-impregnated discs, are used to protect the CVAD insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the
catheter. New products, including tissue adhesive (TA), and integrated securement and dressing products (ISD), are
available to clinicians to provide securement and dressings for CVAD. It is not known whether these new products are effective at reducing CVAD failure, in comparison to standard care (BPU and suture). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment,
retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on CVAD failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children
with non-tunnelled CVAD in the paediatric intensive care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59858 0
Dr Debbie Long
Address 59858 0
Paediatric Intensive Care Unit
Lady Cilento Children's Hospital
501 Stanley Street,
South Brisbane QLD 4101
Country 59858 0
Australia
Phone 59858 0
+61 7 3068 1474
Fax 59858 0
Email 59858 0
debbie.long2@health.qld.gov.au
Contact person for public queries
Name 59859 0
Dr Debbie Long
Address 59859 0
Paediatric Intensive Care Unit
Lady Cilento Children's Hospital
501 Stanley Street,
South Brisbane QLD 4101
Country 59859 0
Australia
Phone 59859 0
+61 7 3068 1474
Fax 59859 0
Email 59859 0
debbie.long2@health.qld.gov.au
Contact person for scientific queries
Name 59860 0
Dr Debbie Long
Address 59860 0
Paediatric Intensive Care Unit
Lady Cilento Children's Hospital
501 Stanley Street,
South Brisbane QLD 4101
Country 59860 0
Australia
Phone 59860 0
+61 7 3068 1474
Fax 59860 0
Email 59860 0
debbie.long2@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary