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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]

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.

Lifespan of continuous renal replacement circuit

Condition category

Condition code

Renal and Urogenital

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]

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]

Continuous renal replacement circuit lifespan

Timepoint [1]

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]

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]

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]

Number and duration of dialysis catheter placements

Timepoint [1]

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]

The incidence of atrial arrhythmias, ventricular arrhythmias. The need for blood transfusion. Mechanical complications, such as pneumothorax, or tamponade.

Timepoint [2]

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]

Average dose of heparin used, acquired from the intensive care bed side chart

Timepoint [3]

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]

Mortality, intensive care unit [ICU] and hospital length of stays

Timepoint [4]

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]

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]

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?

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]

6000

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Perth Hospital Ethics Committee

Ethics committee address [1]

Royal Perth Hospital Ethics Committee Kirkman House Wellington Street Campus GPO Box X2213 PERTH WA 6847

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/02/2009

Approval date [1]

21/12/2009

Ethics approval number [1]

RPHEC 2009-005

Summary

Brief summary

A well functioning short-term dialysis catheter (STDC) is of paramount importance in establishing a sufficient, reliable blood flow necessary for the delivery of adequate dialysis during continuous renal replacement therapy (CRRT). The optimal position for the proximal opening of a STDC in critically ill patients with acute kidney injury (AKI) is not well studied and remains controversial. Placing the proximal tip of a STDC in right atrium (RA) may improve blood flow through the STDC and CRRT circuit by reducing the impedance caused by collapsing great thoracic vein (GTV) vessel walls against the STDC when placing the tip of the catheter in the superior vena cava (SVC). Improving blood flow through the CRRT circuit may, in turn, improve dialyser lifespan, dialysis dose delivery, reduced blood loss and thus reduce the costs and nursing workload from setting up of new CRRT circuits. 
At the centre of this debate is the safety of positioning the proximal tip of a STDC in the RA. When utilizing the GTV, either internal jugular or subclavian vein, for central vascular access, traditional teaching is to avoid placing the tip of the central venous catheter (CVC) in the RA to reduce the risk of atrial arrhythmia, RA wall perforation and cardiac tamponade. Recent evidence, however, suggests that it is the techniques of CVC insertion that are more important than the position of the tip of the CVC in determining the subsequent risk of atrial perforation and cardiac tamponade. Furthermore, it is common practice for long-term tunnelled dialysis catheters to be placed in the RA for improved flow with reports of atrial perforation and cardiac tamponade from such practices being exceeding rare. We hypothesized that placing a soft silicone STDC in the RA is safe, may prolong dialyser circuit lifespan, and improve dialysis intensity delivery of CRRT when compared to placing the proximal tip of the STDC within the SVC in critically ill patients with AKI requiring CRRT.

Trial website

Nil

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr David Morgan

Address

Intensive Care Department
Level 4 North Block
Royal Perth Hospital
Wellington Street, WA 6000

Country

Australia

Phone

+61 8 9224 2603

Fax

davidintoronto2004@hotmail.com

Contact person for scientific queries

Name

Dr David Morgan

Address

Intensive Care Department
Level 4 North Block
Royal Perth Hospital
Wellington Street, WA 6000

Country

Australia

Phone

+61 8 9224 2603

Fax

davidintoronto2004@hotmail.com

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

Source	Title	Year of Publication	DOI
Dimensions AI	Patient Factors Associated with Frequent Clotting of Dialysers during Haemodiafiltration in Critically Ill Patients: A Post Hoc Analysis of a Randomised Controlled Study	2014	https://doi.org/10.1177/0310057x1404200111

N.B. These documents automatically identified may not have been verified by the study sponsor.

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