An interventional study of Temporary central dialysis catheterization in Subclavian Vein Stenosis and Jugular Vein Occlusion, sponsored by Skane University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Skane University Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →Skane University Hospital is the lead sponsor of 73 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The temporary central dialysis catheter is placed in the right subclavian vein.
Procedure: Temporary central dialysis catheterization
The temporary central dialysis catheter is placed in the right internal jugular vein.
Procedure: Temporary central dialysis catheterization
Placement of temporary central dialysis catheter
Central vein stenosis
\>50 percent central vein diameter reduction (stenosis) using CT venography
Time frame: 1.5-3 months after the catheterization
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
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
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
Dialysis problems
Blood flow rates and interruptions during dialysis are compared between the groups
Time frame: During dialysis sessions
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