Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001033033
Ethics application status
Approved
Date submitted
17/11/2010
Date registered
24/11/2010
Date last updated
31/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two venous access catheters for continuous haemofiltration in Intensive Care
Scientific title
In Intensive Care patients receiving haemofiltration is the Niagara or the Dolphin vasocath model more effective in terms of ease of insertion, infection rate, filter life and time to device failure?
Secondary ID [1] 253114 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
TARIF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute renal failure 258674 0
Condition category
Condition code
Renal and Urogenital 258820 258820 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Routine insertion of Dolphin protect vascular access device for haemofiltration
Arm 2: Routine insertion of Niagara vascular access device for haemofiltration

The Niagara device has large diameter channels, allowing high blood flows, but it occasionally can be difficult to insert as of its shape with a shoulder within the catheter. The Dolphin Gambro catheter has a wedge shape, which might make insertion easier and the catheter is impregnated with an antibacterial material that might reduce the rate of infection.

Survival analysis will be used to examine duration of catheter placement and haemofilter life. Vascular access devices are retained for about seven days on average. Haemofilters generally last 12-36 hours. Therefore several haemofilters may be used for each vascular access device. Haemofiler life may be a surrogate measure of vascular access efficacy.
Intervention code [1] 257635 0
Treatment: Devices
Comparator / control treatment
Vascular access catheters Dolphin versus Niagara model
Control group
Active

Outcomes
Primary outcome [1] 259684 0
transaccess resistance (mathematically derived measure of the ease of blood flow through the catheter
Timepoint [1] 259684 0
Duration of haemofiltration
Secondary outcome [1] 266376 0
time to insert catheter
Timepoint [1] 266376 0
in minutes
Secondary outcome [2] 266377 0
Ease of insertion of vascular access catheter
Timepoint [2] 266377 0
visual analog scale done after insertion by the doctor performing the procedure
Secondary outcome [3] 266378 0
Presence of colonisation of the catheter at the time of removal
Timepoint [3] 266378 0
All tips will be send for culture-timeframe for laboratory 3-5 days
Secondary outcome [4] 266379 0
Presence of skin erythema at insertion site at time of removal
Timepoint [4] 266379 0
at time of removal of vascular access device
Secondary outcome [5] 266380 0
Haemofilter life
Timepoint [5] 266380 0
Time of failure of haemofilters connected via the test cannula

Eligibility
Key inclusion criteria
Patients requiring haemofiltration for acute renal failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to material of vascular device

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)
Before insertion of the vascular device the doctor opens a sealed opaque envelope specifying with device to use and which access site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization
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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258090 0
Self funded/Unfunded
Name [1] 258090 0
Country [1] 258090 0
Australia
Primary sponsor type
Individual
Name
Kieran Hogan
Address
Dept of ICU, Cabrini Hospital, 183 Wattletree Road, Malvern Vic 3144
Country
Australia
Secondary sponsor category [1] 257270 0
None
Name [1] 257270 0
Address [1] 257270 0
Country [1] 257270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260082 0
Cabrini Institute Ethics Commitee
Ethics committee address [1] 260082 0
183 Wattletree Road
Malvern Vic 3144
Ethics committee country [1] 260082 0
Australia
Date submitted for ethics approval [1] 260082 0
18/11/2010
Approval date [1] 260082 0
Ethics approval number [1] 260082 0

Summary
Brief summary
Continuous haemofiltration is performed in ICU to support patients with acute renal failure. The patient’s blood is pumped through a haemofilter where uraemic toxins are removed and then it is returned to the circulation. This is a continuous process that necessitates safe reliable large bore access to the circulation. The vascular access catheters are inserted percutaneously, usually into the femoral or internal jugular veins. There are number of commercial vascular access catheters available, but the industry standard for the past 10 years has been Bard Niagra, Bard Access Systems Inc. Utah, USA. This has large diameter channels, allowing high blood flows, but it occasionally can be difficult to insert. A new product, the Gambro Dolphin Protect, Gambro Lund Sweden, vascular access catheter has become available. It has a similar wide bore channels, but the shape of the cannula might make insertion easier and the catheter is impregnated with an antibacterial material that might reduce the rate of infection. These claimed advantages are only valuable if its basic function matches that of the industry standard.
The aim of this study is to compare the two vascular access devices in a randomised controlled trial. The primary outcome measure will be trans-access resistance, a mathematically derived measure of the ease of blood flow through the catheter. Secondary outcome measures will be time to insert (in minutes) and ease of insertion measured on a visual analogue scale, presence of colonisation of the catheter at the time of removal (all tips will be sent for culture), presence of skin erythema at insertion site at time of removal, and haemofilter life (time to failure of haemofilters connected via the test cannula).
Trial website
none
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 31928 0
Address 31928 0
Country 31928 0
Phone 31928 0
Fax 31928 0
Email 31928 0
Contact person for public queries
Name 15175 0
Kieran Hogan
Address 15175 0
Dept of ICU, Cabrini Hospital, 183 Wattletree Road, Malvern Vic 3144
Country 15175 0
Australia
Phone 15175 0
+61-95081712
Fax 15175 0
++61395081003
Email 15175 0
[email protected]
Contact person for scientific queries
Name 6103 0
Dr John Reeves, MBBS, MD, FANZCA, FCICM, EDIC
Address 6103 0
Cabrini Hospital
Intensive Care Unit
183 Wattletree Road
Malvern Vic 3144
Country 6103 0
Australia
Phone 6103 0
+61395081713
Fax 6103 0
+61395081003
Email 6103 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
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