Central Vein Stenosis Due to Dialysis Catheter Insertion in Subclavian Compared to Jugular Vein

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkane University Hospital

About this trial

Central vein stenosis (CVS) is a well-known complication of central venous catheterization, especially after insertion of temporary hemodialysis catheters (tHDC). Incidence and prevalence differ between studies, and exact figures are hard to tell since proper venographies seldom are performed unless the patient is symptomatic.

Most tHDC are placed in the jugular or femoral veins as catheters in the subclavian veins have been shown to result in CVS to a greater degree. However, some studies are equivocal and there are several advantages with the subclavian vein such as a lower risk for infectious and thrombotic complications, longer durability (thereby avoiding placement of a new catheter with repeated tissue trauma), increased comfort during insertion and use, less effect on blood flow if the patient moves the head, easier to mobilize.

The studies on CVS incidence originate from the 1990s when ultrasound-guided insertions were unheard of and polyurethane catheters were prevalent. The investigators believe that there is less tissue trauma when using ultrasound guidance in real-time. Furthermore, CVS is less common when silicone catheters are used instead of polyurethane catheters.

To avoid unnecessary vascular trauma and patient suffering, any pre-existing CVS should ideally be detected before cannulation attempts. A CT scan of the chest with IV contrast is preferred, but this exposes the patient to ionized radiation, is time-consuming and (although debated) may cause contrast-induced nephropathy. A brief ultrasound examination to verify central venous patency would be useful provided it is shown to have an adequate sensitivity for stenosis detection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (18 years of age or older).

In need of a tCDC with an expected treatment time of at least 7 days.

Informed consent.

Disqualifiers

Intravenous pacemaker or a PICC-line via right-sided central veins in situ.

Known right-sided CVS.

AV fistula on the right upper extremity.

History of central venous vascular interventions including stents, dilatations and more (but not previous central venous catheterization).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Temporary central dialysis catheterization

    Procedure/Surgery

    Placement of temporary central dialysis catheter

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Right subclavian vein catheterizationActive comparator 1 intervention
Group B: Right internal jugular vein catheterizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Central vein stenosis

\>50 percent central vein diameter reduction (stenosis) using CT venography

Time frame
1.5-3 months after the catheterization

Secondary outcomes

1

Ultrasound-guided assessment of central vein stenosis (50 percent threshold)

Ultrasound-derived parameters indicating central vein stenosis are compared to CT venography results (with a threshold of 50 percent venous diameter reduction)

Time frame
1.5-3 months after the catheterization
2

Ultrasound-guided assessment of central vein stenosis (80 percent threshold)

Ultrasound-derived parameters indicating central vein stenosis are compared to CT venography results (with a threshold of 80 percent venous diameter reduction)

Time frame
1.5-3 months after the catheterization
3

Patient experience

Questionnaire regarding the patient's experience of discomfort during the catheterization procedure and when carrying the catheter

Time frame
Immediately after catheterization and 3-6 months after the catheterization
4

Dialysis problems

Blood flow rates and interruptions during dialysis are compared between the groups

Time frame
During dialysis sessions

Other outcomes

Sponsors and contacts

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