Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000759998
Ethics application status
Approved
Date submitted
24/02/2010
Date registered
20/07/2011
Date last updated
13/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Short Term Dialysis Catheter Position on Dialyser Lifespan.

Unblinded, randomised, controlled trial to assess the effect of placing the proximal tip placement of a short term dialysis catheters on continuous renal replacement (CRRT) circuit lifespan in intensive care unit (ICU) patients with severe acute kidney injury (AKI).
Scientific title
The Effect of Short Term Dialysis Catheter Position on Dialyser Lifespan. Unblinded, randomised, controlled trial to assess the effect of placing the proximal tip placement of a short term dialysis catheters on continuous renal replacement (CRRT) circuit lifespan in intensive care unit (ICU) patients with severe acute kidney injury (AKI)
Secondary ID [1] 1246 0
Not applicable
Universal Trial Number (UTN)
U1111-1113-1912
Trial acronym
RADICAL (Right Atrium DIalysis Catheter ALignment) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe renal failure in the intensive care unit requiring continuos renal replacement therapy. 256493 0
Lifespan of continuous renal replacement circuit 268364 0
Condition category
Condition code
Renal and Urogenital 256661 256661 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive an Edwards Lifesciences silicone double lumen 13.5F short-term dialysis catheter (STDC) (manufactured by Medical Components, Harleysville, PA, USA). The Edwards Lifesciences STDC is designed with a proximal return lumen and three return side ports lying within 3 cm of the proximal tip. There are four arterial side ports that lie within 3.5cm and 6 cm distal of the proximal end.
In this study, patients will be randomized to receive either a shorter length STDC [15 cm if placed through the right great thoracic vein(GTV) and 20cm if placed through the left GTV] aiming at placing the tip of the STDC in the SVC or a longer length STDC [20 cm if placed in the right GTV and 24cm if placed in the left GTV] aiming at placing the tip of the STDC in the proximal right atrium (RA). The full length of the STDC will be placed inside the GTV by securing the hub of the STDC against the skin at the insertion site. Because the STDCs are labelled clearly with its length at the distal hub of the catheters it was impossible to blind treating clinicians in this study. Other than the length and depth of the STDC placement, the treating physicians were responsible for all other aspects of the continuos renal replacement therapy [CRRT] and clinical care, including when to initiate and cease CRRT, escalation of anticoagulation during CRRT including the use of systemic anticoagulation or citrate dialysis if dialyzer lifespan was judged to be unacceptably short, and whether a change in STDC was necessary due to vascular access problem or catheter-related infection. Dialysis data will be collected from the bedside nursing chart for the duration of the CRRT (if less than 10 days) or until a maximum of 10 days after the initiation of CRRT. Dialysis data was no longer collected if the patient meet one of the exclusion criteria. Exclusion criteria include the use of systematic anticoagulation or citrate dialysis, the placement of the STDC in the femoral vein or requirement of a tunnelled long-term dialysis catheter. Patients requiring a change in STDC due to suspected catheter-related infection or vascular access problem would receive a STDC with its proximal tip targeted at the same position according to their initial randomization status and remain in the study until they reach an above endpoint. Therefore some patients will require more than one intervention. Data about complications from placing the STDC will be collected for the duration that the STDC remains insitu regardless of whether the patient is receiving CRRT, intermittent haemodialysis or no renal replacement therapy. All patients receive a portable CXR following the insertion of a STDC. Two thoracic radiologists, who are blinded to the randomization status of the patients, will reported the position of the proximal tip of each patient and this report was not available to the treating physicians.
Intervention code [1] 255776 0
Treatment: Devices
Comparator / control treatment
Positioning the proximal tip/end of a short-term dialysis catheter in the superior vena cava
Control group
Active

Outcomes
Primary outcome [1] 257556 0
Continuous renal replacement circuit lifespan
Timepoint [1] 257556 0
From the time of insertion of the short term dialysis catheter until the patient no longer needs continuous reanl replacement therapy [CRRT], or the patient has received 10 days of CRRT, or until the patients meets an exclusion criteria such as changing to citrate dialysis.
Primary outcome [2] 257557 0
Dialysis intensity (effluent x time) delivery. As a percentage the amount of dialysis intensity received by a patient over 24 hours divided by the dialysis intesity prescribed based on a 24 hour day
Timepoint [2] 257557 0
From the time of insertion of the STDC until the patient no longer needs CRRT or the patient has recieved 10 days of CRRT or until the patients meets an exclusion criteria such as changing to citrate dialysis.
Secondary outcome [1] 262799 0
Number and duration of dialysis catheter placements
Timepoint [1] 262799 0
Measured from time on study enrollement until patients no longer needs a STDC and this is removed from the patient's body.
Secondary outcome [2] 262800 0
The incidence of atrial arrhythmias, ventricular arrhythmias. The need for blood transfusion. Mechanical complications, such as pneumothorax, or tamponade.
Timepoint [2] 262800 0
Measured from time on study enrollement until patients no longer needs a STDC and this is removed from the patient's body.
Secondary outcome [3] 262801 0
Average dose of heparin used, acquired from the intensive care bed side chart
Timepoint [3] 262801 0
From the time of insertion of the STDC until the patient no longer needs CRRT or the patient has received 10 days of CRRT or until the patients meets an exclusion criteria such as changing to citrate dialysis.
Secondary outcome [4] 262802 0
Mortality, intensive care unit [ICU] and hospital length of stays
Timepoint [4] 262802 0
Measured from time of admission to the hospital and intensive care unit until the time of discharge from the ICU and hospital
Secondary outcome [5] 262803 0
Reasons for dialyser failure (electively taken down, dialyser clotting, vascular access, dialysis machine set up/malfunction).This information will be obtained from the intensive care bedside chart.
Timepoint [5] 262803 0
From the time of insertion of the STDC until the patient no longer needs CRRT, or the patient has received 10 days of CRRT, or until the patients meets an exclusion criteria such as changing to citrate dialysis.

Eligibility
Key inclusion criteria
Patients renal failure in the intensive care unit who require the placement of a short-term dialysis catheter inserted via the subclavian or internal jugular veins for continuous renal replacement therapy [CRRT]
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having the short term dialysis catheter inserted via the femoral vein. Patients who require systemic or regional anticoagulation for reasons other than dialysis. Patients with a clinical indication for a tunnelled long-term dialysis catheter.

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)
All patients requiring short term dialysis catheters in the subclavian or internal jugular vein will be considered. Patients able to consent directly with sign a consent form. Those patients unable to consent have been granted a "waiver of consent" by the hospital ethics committee. A next of kin form will be give to family with the option to withdraw the patient. Treatment will be allocated by the treating physician accessing a sequentially numbered sealed envelop which contains a randomly asigned dialysis catheter length based on the physicians choose of great thoracic vein.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
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
Completed
Date of first participant enrolment
Anticipated
10/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2379 0
6000

Funding & Sponsors
Funding source category [1] 256261 0
Self funded/Unfunded
Name [1] 256261 0
Country [1] 256261 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street Campus
GPO Box X2213
PERTH WA 6847
Country
Australia
Secondary sponsor category [1] 251591 0
None
Name [1] 251591 0
Address [1] 251591 0
Country [1] 251591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258353 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 258353 0
Ethics committee country [1] 258353 0
Australia
Date submitted for ethics approval [1] 258353 0
04/02/2009
Approval date [1] 258353 0
21/12/2009
Ethics approval number [1] 258353 0
RPHEC 2009-005

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

Contacts
Principal investigator
Name 30674 0
Address 30674 0
Country 30674 0
Phone 30674 0
Fax 30674 0
Email 30674 0
Contact person for public queries
Name 13921 0
Dr David Morgan
Address 13921 0
Intensive Care Department
Level 4 North Block
Royal Perth Hospital
Wellington Street, WA 6000
Country 13921 0
Australia
Phone 13921 0
+61 8 9224 2603
Fax 13921 0
Email 13921 0
[email protected]
Contact person for scientific queries
Name 4849 0
Dr David Morgan
Address 4849 0
Intensive Care Department
Level 4 North Block
Royal Perth Hospital
Wellington Street, WA 6000
Country 4849 0
Australia
Phone 4849 0
+61 8 9224 2603
Fax 4849 0
Email 4849 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
SourceTitleYear of PublicationDOI
Dimensions AIPatient Factors Associated with Frequent Clotting of Dialysers during Haemodiafiltration in Critically Ill Patients: A Post Hoc Analysis of a Randomised Controlled Study2014https://doi.org/10.1177/0310057x1404200111
N.B. These documents automatically identified may not have been verified by the study sponsor.