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

NCT04871568 | Recruiting

• 1 other identifier: CDC stenosis
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Jugular Vein Occlusion; Subclavian Vein Stenosis

Keywords

Central Venous Stenosis

Outcome Measures

Primary Outcomes (1)

• Central vein stenosis

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

  1.5-3 months after the catheterization

Secondary Outcomes (4)

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

  1.5-3 months after the catheterization

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

  1.5-3 months after the catheterization

• Patient experience

  Immediately after catheterization and 3-6 months after the catheterization

• Dialysis problems

  During dialysis sessions

Study Arms (2)

Right subclavian vein catheterization

ACTIVE COMPARATOR

The temporary central dialysis catheter is placed in the right subclavian vein.

Procedure: Temporary central dialysis catheterization

Right internal jugular vein catheterization

ACTIVE COMPARATOR

The temporary central dialysis catheter is placed in the right internal jugular vein.

Procedure: Temporary central dialysis catheterization

Interventions

Temporary central dialysis catheterization PROCEDURE

Placement of temporary central dialysis catheter

Right internal jugular vein catheterization; Right subclavian vein catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years of age or older).
• In need of a tCDC with an expected treatment time of at least 7 days.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skane University Hospital: lead

Study Sites (1)

Skånes universitetssjukhus

Lund, 22185, Sweden

RECRUITING

Related Publications (1)

• Borgquist O, Naddi L, Bozovic G, Hellberg M, Annborn M, Sjovall F, Adrian M, Hettinger E, Sjoberg P, Kander T. Central venous stenosis after subclavian versus internal jugular dialysis catheter insertion (CITES) in adults in need of a temporary central dialysis catheter: study protocol for a two-arm, parallel-group, non-inferiority randomised controlled trial. Trials. 2023 May 12;24(1):327. doi: 10.1186/s13063-023-07350-9.

  PMID: 37173715 DERIVED

Study Officials

• Ola Borgquist, MD, PhD

  Skånes universitetssjukhus

  PRINCIPAL INVESTIGATOR

• Thomas Kander, MD, PhD

  Skånes universitetssjukhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ola Borgquist, MD, PhD

CONTACT

+46704156334; oborgquist@gmail.com

Thomas Kander, MD, PhD

CONTACT

thomas.kander@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 4, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

SE (1)