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

Study acronym: CITES
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Sep 30, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Minor Secondary endpoints: details revised at 2 of 4 entriesv5
  4. Notable Primary completion date: Sep 30, 2023 to Sep 30, 2025
    • Study completion date: Dec 31, 2023 to Dec 31, 2025
    v4
  5. Minor Eligibility criteria shortened, about 7 words
    • Study description shortened, about 2 words
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Sep 15, 2021 to Nov 15, 2021
    • Secondary endpoints revised (4)
    • Study description shortened, about 8 words
    • Site details revised
    • Eligibility criteria shortened, about 1 word
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04871568
Lead Sponsor Skane University Hospital
Conditions
(from sponsor)
Subclavian Vein Stenosis, Jugular Vein Occlusion
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov