Central Vein Stenosis Due to Dialysis Catheter Insertion in Subclavian Compared to Jugular Vein
NCT ID: NCT04871568
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-11-15
2025-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Right subclavian vein catheterization
The temporary central dialysis catheter is placed in the right subclavian vein.
Temporary central dialysis catheterization
Placement of temporary central dialysis catheter
Right internal jugular vein catheterization
The temporary central dialysis catheter is placed in the right internal jugular vein.
Temporary central dialysis catheterization
Placement of temporary central dialysis catheter
Interventions
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Temporary central dialysis catheterization
Placement of temporary central dialysis catheter
Eligibility Criteria
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Inclusion Criteria
* In need of a tCDC with an expected treatment time of at least 7 days.
* Informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Skane University Hospital
OTHER
Responsible Party
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Ola Borgquist
Principal Investigator
Principal Investigators
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Ola Borgquist, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Skånes universitetssjukhus
Thomas Kander, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Skånes universitetssjukhus
Locations
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Skånes universitetssjukhus
Lund, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Ola Borgquist, MD, PhD
Role: primary
Thomas Kander, MD, PhD
Role: backup
References
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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.
Other Identifiers
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CDC stenosis
Identifier Type: -
Identifier Source: org_study_id