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Trial registered on ANZCTR


Registration number
ACTRN12615000667516
Ethics application status
Approved
Date submitted
16/06/2015
Date registered
26/06/2015
Date last updated
4/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Central venous Access device SeCurement And Dressing Effectiveness in the ICU: the CASCADE ICU Trial
Scientific title
Randomised controlled trial of tissue adhesive, integrated securement products or external stabilisation devices versus standard care (bordered polyurethane) dressings to prevent central venous access device failure in intensive care patients with non-tunnelled, percutaneous central venous access devices: the CASCADE ICU trial
Secondary ID [1] 286916 0
Nil
Universal Trial Number (UTN)
U1111-1171-2082
Trial acronym
CASCADE ICU Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device failure prior to completion of therapy 295337 0
Condition category
Condition code
Public Health 295604 295604 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 adult intensive care departments. Consenting patients will have their 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. Within this study it will be applied to the CVAD insertion site, and used in addition to a chlorhexidine-impregnated bordered polyurethane dressing and sutures.
Arm 2: Sutureless Stabilisation Device (SSD) have a large adhesive padded footplate with locking clasp made of hard plastic or self-gripping soft fasteners. SSD are used in addition to bordered polyurethane.
Arm 3: Integrated securement and dressing products which combine the durability and visibility of the transparent polyurethane, whilst including an absorbent pad and additional security via bordering. A chlorhexidine-impregnated disc and suture will also be used.
Arm 4 (Control): Bordered polyurethane (BPU) dressings involve a clear polyurethane with an added external adhesive border of foam or cloth fabric. They are routinely used in conjunction with suture and are chlorhexidine impregnated.
The randomly allocated dressing will be applied until completion of therapy. The dressing will be applied at CVAD insertion and then changed every 7 days, or on disruption of the dressing integrity.
Intervention code [1] 292102 0
Prevention
Intervention code [2] 292156 0
Treatment: Devices
Comparator / control treatment
Control group patients will have their central venous access devices secured with bordered polyurethane (BPU) dressings which are chlorhexidine impregnated, and are used in conjunction with suture.
Control group
Active

Outcomes
Primary outcome [1] 295318 0
Feasibility of a full efficacy trial, established by a composite analyses of: eligibility, recruitment, retention and attrition, protocol adherence, missing data, intervention acceptability and effect size estimates. The primary outcome for the full efficacy trial which requires and effect size estimate is all-cause CVAD failure.
Timepoint [1] 295318 0
Study completion
Primary outcome [2] 295319 0
CVAD failure: all-cause CVAD failure (composite of infection, occlusion, dislodgement, thrombosis, haematoma or breakage). Device failure is the outcome of importance to patients, with poor securement and dressing taking various pathways to the same endpoint – CVAD removal with requirement for a new CVAD insertion
Timepoint [2] 295319 0
CVAD removal
Secondary outcome [1] 315342 0
Central line-associated bloodstream infection (CLABSI): A laboratory confirmed bloodstream infection (LCBSI) that is not secondary to an infection at another body site (NHSN criteria) (excludes Mucosal Barrier Injury LCBSI) with CVAD in place for >2 days when all elements of LCBI were first present together. Determined by blinded infectious disease specialist.
Timepoint [1] 315342 0
CVAD removal
Secondary outcome [2] 315343 0
Local infection: Purulent phlebitis confirmed with a positive (>15cfu) CVAD tip culture, but with negative or no blood culture
Timepoint [2] 315343 0
CVAD removal
Secondary outcome [3] 315344 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 vena cava (diagnosed by xray/leakage from site on injection). Complete: CVAD body completely leaves the vein.
Timepoint [3] 315344 0
CVAD removal
Secondary outcome [4] 315345 0
Occlusion Partial: 1 or more lumens cannot be flushed and/or aspirated, or resolved after anticoagulant dwell. Complete: all lumens cannot be flushed and/or aspirated despite anticoagulant dwell.
Timepoint [4] 315345 0
CVAD removal
Secondary outcome [5] 315346 0
Thrombosis: Development of thrombosed vessel (partial or complete) at the CVAD site diagnosed on ultrasound as requested by the treating clinician for suspected thrombosis
Timepoint [5] 315346 0
CVAD removal
Secondary outcome [6] 315347 0
CVAD breakage: Visible split in CVAD material diagnosed by leakage or radiographic evidence of extravasation from a portion of the CVAD into tissue
Timepoint [6] 315347 0
CVAD removal
Secondary outcome [7] 315348 0
Primary bloodstream infections: positive blood culture and clinical signs or symptoms of localized infection at the CVAD site, but no other infection can be found
Timepoint [7] 315348 0
CVAD removal
Secondary outcome [8] 315349 0
All bloodstream infections: Any positive blood culture that meets the CDC NHSN criteria for Laboratory Confirmed Bloodstream Infection (LCBSI), excluding mucosal barrier-LCBSI
Timepoint [8] 315349 0
CVAD removal
Secondary outcome [9] 315350 0
Securement-dressing failure: Replacement < 7 days for loose, missing, bloodstained, diaphoresis or secretion soaked dressings
Timepoint [9] 315350 0
7 days post application
Secondary outcome [10] 315351 0
CVAD & 1st securement-dressing dwell time: hours from insertion/application until removal
Timepoint [10] 315351 0
CVAD failure, dressing failure
Secondary outcome [11] 315352 0
CVAD strength: tensile strength post CVAD removal
Timepoint [11] 315352 0
CVAD removal
Secondary outcome [12] 315353 0
Patient and staff satisfaction: using 0-10 NRS and interview
Timepoint [12] 315353 0
Dressing application and CVAD removal
Secondary outcome [13] 315354 0
Safety endpoints: Skin rash, skin tears, blisters, pruritis, local or systemic allergic reaction.
Timepoint [13] 315354 0
CVAD removal
Secondary outcome [14] 315355 0
Costs: all healthcare utilisation costs; composite of dressings, complications.
Timepoint [14] 315355 0
Study completion
Secondary outcome [15] 318635 0
Haematoma around CVAD site: Significant haematoma / bruise around CVAD site
Timepoint [15] 318635 0
CVAD removal

Eligibility
Key inclusion criteria
1. Informed written consent
2. Non-tunnelled percutaneous CVAD to be inserted in ICU for clinical care for >24 hours
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Peripherally inserted, tunnelled, dialysis, or pulmonary artery catheters;
2. Current bloodstream infection;
3. CVAD to be inserted through diseased, burned, scarred or hirsute skin;
4. Allergy to any study product;
5. Previous study enrolment in this 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 (RN) will screen patients daily (screening log kept), gain informed consent, and perform randomisation. The RN will have the study products in pre-packs and liaise closely with the ordering and inserting intensivist. All elligible patients (or their representative) will be approached for written informed consent by the RN. 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 stratified by hospital site. Randomisation will be in a 1:1:1:1 ratio between the four 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
N/A
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility outcomes will be assessed using descriptive statistics. Analysis will be intention to treat with patients the unit of measurement. Baseline group comparisons will be by clinical parameters. Relative incidence rates of CVAD and dressing failure/100 devices and /1,000 device days (95% CIs) will summarise treatment impacts, with group differences tested. Kaplan-Meier survival curves (+ log rank Mantel-Cox test) will compare failure over time. Secondary endpoints of dwell-time, costs, dislodgement, occlusion, thrombosis, colonisation (skin/tip), infection (local/CLABSI/CRBSI/ BSIs), breakage, patient/staff satisfaction scores, adverse events and treatment group failures will be compared between groups using parametric/nonparametric techniques. Cox regression will test the effect of patient and device variables associated with failure e.g. insertion site, antimicrobial catheters, delirium. Analyses will adjust for stratification factors, and regression models will allow for clustering by hospital/ward. Data will be exported into PASW after cleaning outlying figures, missing and implausible data, with a random 5% sample of source data re-checked. All attempts will be made to collect the primary endpoint. Missing data will be modelled for best- and worst-case outcomes. A per-protocol analysis will assess the effect of protocol violations. P <0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2015
Actual
30/11/2015
Date of last participant enrolment
Anticipated
30/04/2018
Actual
5/07/2018
Date of last data collection
Anticipated
14/05/2018
Actual
20/07/2018
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3926 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 9841 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 291475 0
Charities/Societies/Foundations
Name [1] 291475 0
Intensive Care Foundation
Country [1] 291475 0
Australia
Funding source category [2] 292319 0
University
Name [2] 292319 0
Centre for Health Practice Innovation; Menzies Health Institute Queensland
Country [2] 292319 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Marion Mitchell
Address
School of Nursing and Midwifery
Nurse Practice Development Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 290154 0
None
Name [1] 290154 0
Address [1] 290154 0
Country [1] 290154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293023 0
Royal Brisbane and Women's Health Service
Ethics committee address [1] 293023 0
Butterfield Street
Herston, QUEENSLAND, 4029
Ethics committee country [1] 293023 0
Date submitted for ethics approval [1] 293023 0
Approval date [1] 293023 0
10/02/2014
Ethics approval number [1] 293023 0
HREC/13/QRBW/454

Summary
Brief summary
About 500,000 Australians need a Central Venous Access Device (CVAD) each year for intravenous administration of medicines, chemotherapy and fluids. Insertion of these devices poses great procedural risk and complications are common during subsequent use. Between 20 and 50% of CVADs fail prior to treatment being complete. This includes CVADs becoming partially or wholly dislodged, occluded, thrombosis of the vein, fractured catheters, severe pain, or a bloodstream infection. These complications are associated with patient suffering, prolonged hospitalisation, more expensive healthcare costs and increased mortality.

Two key factors in preventing complications are (i) securement - that CVADs are adequately secured to the skin, and (ii) dressings - that the incision is covered to prevent infection. CVAD securement has traditionally been via sutures, with a simple polyurethane dressing. This approach (sutures plus simple polyurethane) has been dominant since the 1980s, despite significant evidence of increased bloodstream infections. New alternative securement and dressing options have become available that may be superior to suture and simple polyurethane dressings for preventing complications, but these have not yet been adequately tested for efficacy or cost-effectiveness.

CVAD securement and dressings cost the Australian health system millions of dollars each year, yet there is currently no high quality evidence from independent trials to guide decision making and practice on this topic. The proposed study is a high quality, pilot randomised controlled trial, designed to assess the feasibility of undertaking a full-scale efficacy randomised controlled trial, and provide preliminary data for an NHMRC project grant application. The full study would aim identify clinically- and cost-effective securement and dressing approaches that prevent CVAD failure. The 4 group trial will test 3 alternatives to standard care, a novel product – tissue adhesive (medical super-glue), and two commercial alternatives. This design will efficiently and rapidly test numerous treatments. The trial will additionally evaluate the acceptability of products to patients and clinicians, and apply an integrated approach to knowledge translation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58118 0
A/Prof Marion Mitchell
Address 58118 0
Nurse Practice Development Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 58118 0
Australia
Phone 58118 0
+61 7 3176 7772
Fax 58118 0
Email 58118 0
[email protected]
Contact person for public queries
Name 58119 0
Marion Mitchell
Address 58119 0
Nurse Practice Development Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 58119 0
Australia
Phone 58119 0
+61 7 3176 7772
Fax 58119 0
Email 58119 0
[email protected]
Contact person for scientific queries
Name 58120 0
Marion Mitchell
Address 58120 0
Nurse Practice Development Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 58120 0
Australia
Phone 58120 0
+61 7 3176 7772
Fax 58120 0
Email 58120 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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