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NCT Number: NCT04871568

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

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.

Recruiting

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Key information

Conditions

Subclavian Vein Stenosis Jugular Vein Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a multicentric, prospective, randomized, controlled, assessor-blinded, non-inferiority trial. Patients will be enrolled in three hospitals (Lund, Malmö, Helsingborg) in southern Sweden. The trial is investigator-initiated and non-commercial. The radiologist interpreting CT venographies will be blinded to study group allocation, whereas the patient, the treating physicians and other care providers will not be blinded.

Patients will be randomized to receive a silicone tCDC either in the right subclavian vein (intervention) or in the right internal jugular vein (control). All catheterizations will be performed in a standardized manner. A questionnaire regarding the patient's experience of the catheterization procedure is handed out as soon as possible, preferably immediately after catheterization if the clinical situation permits.

Follow-up is carried out 3-6 months after the removal of the catheter to eliminate transitory thrombosis. A CT venography with a customized protocol for this study will be performed to look for CVS. An ultrasound examination of the central veins is performed and compared to the findings of the CT venography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temporary central dialysis catheterization

Procedure

Placement of temporary central dialysis catheter

Primary outcomes

  1. Central vein stenosis

    Time frame: 1.5-3 months after the catheterization

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

Secondary outcomes

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

    Time frame: 1.5-3 months after the catheterization

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

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

    Time frame: 1.5-3 months after the catheterization

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

  3. Patient experience

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

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

  4. Dialysis problems

    Time frame: During dialysis sessions

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ola Borgquist, MD, PhD

CONTACT

[email protected]

+46704156334

Thomas Kander, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study title

Central Venous Stenosis Incidence After Right-sided Subclavian and Internal Jugular Vein Catheterization With a Silicone Temporary Hemodialysis Catheter

Acronym: CITES

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 4, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.