Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial

Introduction Current evidence on vascular access strategies for haemodialysis patients is based on observational studies that are at high risk of selection bias. For elderly patients, autologous arteriovenous fistulas that are typically created in usual care may not be the best option because a significant proportion of fistulas either fail to mature or remain unused. In addition, long-term complications associated with arteriovenous grafts and central venous catheters may be less relevant when considering the limited life expectancy of these patients. Therefore, we designed the Optimising Access Surgery in Senior Haemodialysis Patients (OASIS) trial to determine the best strategy for vascular access creation in elderly haemodialysis patients. Methods and analysis OASIS is a multicentre randomised controlled trial with an equal participant allocation in three treatment arms. Patients aged 70 years or older who are expected to initiate haemodialysis treatment in the next 6 months or who have started haemodialysis urgently with a catheter will be enrolled. To detect and exclude patients with an unusually long life expectancy, we will use a previously published mortality prediction model after external validation. Participants allocated to the usual care arm will be treated according to current guidelines on vascular access creation and will undergo fistula creation. Participants allocated to one of the two intervention arms will undergo graft placement or catheter insertion. The primary outcome is the number of access-related interventions required for each patient-year of haemodialysis treatment. We will enrol 195 patients to have sufficient statistical power to detect an absolute decrease of 0.80 interventions per year. Ethics and dissemination Because of clinical equipoise, we believe it is justified to randomly allocate elderly patients to the different vascular access strategies. The study was approved by an accredited medical ethics review committee. The results will be disseminated through peer-reviewed publications and will be implemented in clinical practice guidelines. Protocol version and date V.5, 25 February 2021.Clinical epidemiolog

Central venous catheter-related complications in older haemodialysis patients: A multicentre observational cohort study

Background: Central venous catheters (CVC) remain a commonly used vascular access option in haemodialysis, despite guidelines advising to preferably use arteriovenous fistulae. Compared to younger patients, the risk-benefit ratio of CVC in older patients might be more beneficial, but previous studies mainly focussed on catheter-related bacteraemia and/or assessed tunnelled CVC (TCVC) only. This study's aim was to compare all catheter-related infections and malfunctions in older patients with younger patients using all CVC subtypes. Materials and methods: We used data from DUCATHO, a multicentre observational cohort study in The Netherlands. All adult patients in whom a CVC was placed for haemodialysis between 2012 and 2016 were included. The primary endpoint was the occurrence of catheter-related infections, comparing patients aged > 70 years with patients aged 70 years. No statistically significant difference was found for the occurrence of catheter-related infections (adjusted HR 0.80-95% CI 0.62-1.02), catheter malfunction (adjusted HR 0.94-95% CI 0.75-1.17) and catheter removal due to infection or malfunction (adjusted HR 0.94-95% CI 0.80-1.11). Results were comparable when assessing NTCVC and TCVC separately. Conclusion: Patients aged > 70 to <70 years have a comparable risk for the occurrence of catheter-related infections and catheter malfunction. These findings may help when discussing treatment options with older patients starting haemodialysis and may inform the current debate on the best vascular access for these patients.Nephrolog

Central venous catheter-related complications in older haemodialysis patients: A multicentre observational cohort study

Background: Central venous catheters (CVC) remain a commonly used vascular access option in haemodialysis, despite guidelines advising to preferably use arteriovenous fistulae. Compared to younger patients, the risk-benefit ratio of CVC in older patients might be more beneficial, but previous studies mainly focussed on catheter-related bacteraemia and/or assessed tunnelled CVC (TCVC) only. This study's aim was to compare all catheter-related infections and malfunctions in older patients with younger patients using all CVC subtypes. Materials and methods: We used data from DUCATHO, a multicentre observational cohort study in The Netherlands. All adult patients in whom a CVC was placed for haemodialysis between 2012 and 2016 were included. The primary endpoint was the occurrence of catheter-related infections, comparing patients aged > 70 years with patients aged 70 years. No statistically significant difference was found for the occurrence of catheter-related infections (adjusted HR 0.80-95% CI 0.62-1.02), catheter malfunction (adjusted HR 0.94-95% CI 0.75-1.17) and catheter removal due to infection or malfunction (adjusted HR 0.94-95% CI 0.80-1.11). Results were comparable when assessing NTCVC and TCVC separately. Conclusion: Patients aged > 70 to <70 years have a comparable risk for the occurrence of catheter-related infections and catheter malfunction. These findings may help when discussing treatment options with older patients starting haemodialysis and may inform the current debate on the best vascular access for these patients