Subclavian Vein StenosisCITESNCT04871568
Central Vein Stenosis Due to Dialysis Catheter Insertion in Subclavian Compared to Jugular Vein
A study testing Temporary central dialysis catheterization in people with Subclavian Vein Stenosis and Jugular Vein Occlusion, run by Skane University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subclavian Vein Stenosis, Jugular Vein Occlusion
- What is being tested?
- Temporary central dialysis catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years of age or older).
- In need of a tCDC with an expected treatment time of at least 7 days.
- Informed consent.
Who cannot join
- 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.
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- Known allergy to iodinated contrast agents.
- BMI >35 kg/m2.
- No study physician available for the catheterization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Kander, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Skånes universitetssjukhus
Lund, 22185
Ola Borgquist, MD, PhD, +46704156334, oborgquist@gmail.com
Thomas Kander, MD, PhD, +4646171156
About this study
Official title: Central Venous Stenosis Incidence After Right-sided Subclavian and Internal Jugular Vein Catheterization With a Silicone Temporary Hemodialysis Catheter
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Subclavian Vein Stenosis, Jugular Vein Occlusion
- Being tested
- Temporary central dialysis catheterization
- Keywords
- Central Venous Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary central dialysis catheterizationProcedure or surgery
Placement of temporary central dialysis catheter
| Study group | Role | What they receive |
|---|---|---|
| Right subclavian vein catheterization | Active comparator | The temporary central dialysis catheter is placed in the right subclavian vein. Receives: 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. Receives: Procedure: Temporary central dialysis catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central vein stenosis
>50 percent central vein diameter reduction (stenosis) using CT venography
Measured: 1.5-3 months after the catheterization
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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
Measured: Immediately after catheterization and 3-6 months after the catheterization
Dialysis problems
Blood flow rates and interruptions during dialysis are compared between the groups
Measured: During dialysis sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start15 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subclavian Vein StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Borgquist, Skane University Hospital
- Investigators
- Ola Borgquist, MD, PhD, Principal investigator, Skånes universitetssjukhusThomas Kander, MD, PhD, Principal investigator, Skånes universitetssjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871568
- Sponsor's protocol ID
- CDC stenosis
- Acronym
- CITES
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37173715
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Stenosis Incidence After Right-sided Subclavian and Internal Jugular Vein Catheterization With a Silicone Temporary Hemodialysis Catheter
- ClinicalTrials.gov ID
- NCT04871568
- Acronym / sponsor ID
- CITES / CDC stenosis
- Conditions
- Subclavian Vein Stenosis, Jugular Vein Occlusion
- Keywords
- Central Venous Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right subclavian vein catheterization | Active comparator | Procedure: Temporary central dialysis catheterizationThe temporary central dialysis catheter is placed in the right subclavian vein. |
| Right internal jugular vein catheterization | Active comparator | Procedure: Temporary central dialysis catheterizationThe temporary central dialysis catheter is placed in the right internal jugular vein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18 years of age or older).
- In need of a tCDC with an expected treatment time of at least 7 days.
- Informed consent.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary central dialysis catheterizationPlacement of temporary central dialysis catheter | Procedure or surgery | Right internal jugular vein catheterization, Right subclavian vein catheterization |
Primary outcome
Central vein stenosis
Time frame: 1.5-3 months after the catheterization
>50 percent central vein diameter reduction (stenosis) using CT venography
4 secondary outcomes
Ultrasound-guided assessment of central vein stenosis (50 percent threshold)
Time frame: 1.5-3 months after the catheterization
Ultrasound-guided assessment of central vein stenosis (80 percent threshold)
Time frame: 1.5-3 months after the catheterization
Patient experience
Time frame: Immediately after catheterization and 3-6 months after the catheterization
Dialysis problems
Time frame: During dialysis sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 37173715Borgquist 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Kander, MD, PhD contact
Ola Borgquist, MD, PhD principal investigator
Skånes universitetssjukhus
Thomas Kander, MD, PhD principal investigator
Skånes universitetssjukhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary central dialysis catheterization in people with Subclavian Vein Stenosis and Jugular Vein Occlusion, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ola Borgquist, MD, PhD (+46704156334, oborgquist@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central vein stenosis (time frame: 1.5-3 months after the catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04871568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.