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
Borgquist, Ola LU ; Naddi, Leila LU ; Božović, Gracijela ; Hellberg, Matthias LU ; Annborn, Martin LU ; Sjövall, Fredrik LU
; Adrian, Maria
LU
; Hettinger, Eva
LU
; Sjöberg, Pia
LU
and Kander, Thomas
LU
(2023)
In Trials
24(1).
- 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 subclavian 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... (More)
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 subclavian 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.
(Less)
- author
- Borgquist, Ola
LU
; Naddi, Leila
LU
; Božović, Gracijela
; Hellberg, Matthias
LU
; Annborn, Martin
LU
; Sjövall, Fredrik
LU
; Adrian, Maria
LU
; Hettinger, Eva
LU
; Sjöberg, Pia
LU
and Kander, Thomas
LU
- organization
-
- Clinical Research in Anaesthesia and Intensive Care Medicine (research group)
- Anesthesiology and Intensive Care
- Clinical studies in CKD (research group)
- Nephrology
- Mitochondrial Medicine (research group)
- Integrative Health Research (research group)
- Lund Cardiac MR Group (research group)
- Clinical Physiology (Lund)
- publishing date
- 2023-12
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Adult, Humans, Catheterization, Central Venous/adverse effects, Catheters, Constriction, Pathologic, Jugular Veins/diagnostic imaging, Prospective Studies, Renal Dialysis/adverse effects, Vascular Diseases
- in
- Trials
- volume
- 24
- issue
- 1
- article number
- 327
- publisher
- BioMed Central (BMC)
- external identifiers
-
- scopus:85159170587
- pmid:37173715
- pmid:37173715
- ISSN
- 1745-6215
- DOI
- 10.1186/s13063-023-07350-9
- language
- English
- LU publication?
- yes
- id
- d9e0056b-6926-48e3-9cb3-98a94c394d95
- date added to LUP
- 2023-05-19 20:39:50
- date last changed
- 2024-11-02 17:37:13
@article{d9e0056b-6926-48e3-9cb3-98a94c394d95,
abstract = {{<p>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 subclavian 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.</p>}},
author = {{Borgquist, Ola and Naddi, Leila and Božović, Gracijela and Hellberg, Matthias and Annborn, Martin and Sjövall, Fredrik and Adrian, Maria and Hettinger, Eva and Sjöberg, Pia and Kander, Thomas}},
issn = {{1745-6215}},
keywords = {{Adult; Humans; Catheterization, Central Venous/adverse effects; Catheters; Constriction, Pathologic; Jugular Veins/diagnostic imaging; Prospective Studies; Renal Dialysis/adverse effects; Vascular Diseases}},
language = {{eng}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
series = {{Trials}},
title = {{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}},
url = {{http://dx.doi.org/10.1186/s13063-023-07350-9}},
doi = {{10.1186/s13063-023-07350-9}},
volume = {{24}},
year = {{2023}},
}