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

Study Protocol

Martin Annborn¹  Ola Borgquist²  Maria Adrian²  Pia Sjöberg³  Thomas Kander⁴  Leila Naddi⁴  Fredrik Sjövall⁵  Gracijela Božović⁶  Eva Hettinger⁶  Matthias Hellberg⁷ 

[1] Department of Clinical Sciences Lund, Lund University, Lund, Sweden;Department of Anaesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden;Department of Clinical Sciences Lund, Lund University, Lund, Sweden;Department of Cardiothoracic Surgery, Anaesthesia and Intensive Care, Skåne University Hospital, Lund, Sweden;Department of Clinical Sciences Lund, Lund University, Lund, Sweden;Department of Clinical Physiology, Skåne University Hospital, Lund, Sweden;Department of Clinical Sciences Lund, Lund University, Lund, Sweden;Department of Intensive and Perioperative Care, Skåne University Hospital, Lund, Sweden;Department of Clinical Sciences Lund, Lund University, Lund, Sweden;Department of Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden;Department of Clinical Sciences Lund, Lund University, Lund, Sweden;Department of Medical Imaging and Physiology, Skåne University Hospital, Lund, Sweden;Department of Clinical Sciences Lund, Lund University, Lund, Sweden;Department of Nephrology, Skåne University Hospital, Lund, Sweden;

关键词: Central vein stenosis;    Central venous stenosis;    Subclavian vein;    Internal jugular vein;    Central dialysis catheter;    Right supraclavicular fossa view;    Randomised controlled trial;   

DOI  :  10.1186/s13063-023-07350-9

 received in 2022-06-08, accepted in 2023-05-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsAdult 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.DiscussionThe 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 registrationClinicaltrials.gov; NCT04871568. Prospectively registered on May 4, 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

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