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Recruiting Not applicable

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

NCT04871568 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2021-11-15
Last updated
2026-04-29

Condition(s) studied

Subclavian Vein StenosisJugular Vein Occlusion

Investigational drug(s) / intervention(s)

Temporary central dialysis catheterization

Temporary central dialysis catheterization: Placement of temporary central dialysis catheter

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults (18 years of age or older). * In need of a tCDC with an expected treatment time of at least 7 days. * Informed consent. Exclusion Criteria: * 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). * Central venous catheter in the right internal jugular vein or in the right subclavian vein in situ. * Either the right jugular vein or the right subclavian vein unavailable for catheterization due to, e.g., local skin infection, thrombosis or inability to visualize the vein with ultrasound. * Known allergy to iodinated contrast agents. * BMI \>35 kg/m2. * No study physician available for the catheterization.

Primary outcome measure(s)

  • Central vein stenosis — 1.5-3 months after the catheterization
    \>50 percent central vein diameter reduction (stenosis) using CT venography

Trial sites (1)

FacilityCityRegionStatus
Skånes universitetssjukhus Lund Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04871568 on ClinicalTrials.gov ↗ ← All trials in Sweden