Outcomes {12}
venous diameter reduction, veno-occlusive disease, pain
PNEUMOTHORAX, VENO-OCCLUSIVE DISEASE, DYSFUNCTION, SECONDARY, COMPLICATIONS
The primary outcome is the incidence of post-catheterisation CVS, defined as venous diameter reduction > 50% anywhere from the estimated insertion site to the tip of the catheter, detected by a CT venography performed 1.5–3 months after removal of the tCDC.The CT venography will be performed according to a protocol designed for this trial (Attachment 1) with the purpose to keep the amount of intravenous contrast and radiation as low as possible (with a limit of 100 kV the amount of intravenous contrast is reduced by 30% and less radiation is needed by repositioning the shoulders in an arm holder).The secondary outcomes are:To compare the performance of a focused ultrasound examination of the central veins to detect CVS with a CT venography (golden standard) with a threshold of50% venous diameter reduction, as this is the commonly used definition of CVS80% venous diameter reduction, as it has been suggested that the severity of central veno-occlusive disease must reach a diameter reduction around 80% before upstream changes in blood flow are detectable by current Doppler techniquesTo compare the patients’ experience of discomfort and pain between the groups both during the catheterisation and when carrying the catheter by means of a questionnaire (Additional files To compare catheter blood flow during dialysis and reported catheter-related dialysis dysfunction between the groups. A questionnaire to address this will be filled out by the dialysis nurse after every treatment, including both objective and subjective measures (Additional file To compare the catheterisation success rate (defined as catheter tip placement in the superior vena cava or in the right atrium) between the two groupsTo compare the number of mechanical complications (defined as arterial puncture/catheterisation and pneumothorax) between the groups