Borgquist et al. Trials (2023) 24:327
https://doi.org/10.1186/s13063-023-07350-9
STUDY PROTOCOL
Open Access
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Trials
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
Ola Borgquist
1,2*
, Leila Naddi
1,3
, Gracijela Božović
1,4
, Matthias Hellberg
1,5
, Martin Annborn
1,6
, Fredrik Sjövall
1,7
,
Maria Adrian
1,2
, Eva Hettinger
1,4
, Pia Sjöberg
1,8
and Thomas Kander
1,3
Abstract
Background The right internal jugular vein is currently recommended for temporary central dialysis catheters (tCDC)
based on results from previous studies showing a lower incidence of central vein stenosis compared to the subcla-
vian vein. Data is however conflicting, and there are several advantages when the subclavian route is used for tCDCs.
This prospective, controlled, randomised, non-inferiority study aims to compare the incidence of post-catheterisation
central vein stenosis between the right subclavian and the right internal jugular routes.
Methods Adult patients needing a tCDC will be included from several hospitals and randomised to either subclavian
or internal jugular vein catheterisation with a silicone tCDC. Inclusion continues until 50 patients in each group have
undergone a follow-up CT venography. The primary outcome is the incidence of post-catheterisation central vein
stenosis detected by a CT venography performed 1.5 to 3 months after removal of the tCDC. Secondary outcomes
include between-group comparisons of (I) the patients’ experience of discomfort and pain, (II) any dysfunction of the
tCDC during use, (III) catheterisation success rate and (IV) the number of mechanical complications. Furthermore, the
ability to detect central vein stenosis by a focused ultrasound examination will be evaluated using the CT venography
as golden standard.
Discussion The use of the subclavian route for tCDC placement has largely been abandoned due to older studies
with various methodological issues. However, the subclavian route offers several advantages for the patient. This trial
is designed to provide robust data on the incidence of central vein stenosis after silicone tCDC insertion in the era of
ultrasound-guided catheterisations.
Trial registration Clinicaltrials.gov; NCT04871568. Prospectively registered on May 4, 2021.
*Correspondence:
Ola Borgquist
ola.borgquist@med.lu.se
Full list of author information is available at the end of the article