1. Optimising Access Surgery in Senior Haemodialysis Patients (OASIS)
- Author
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Patrick WHE Vriens, Edith M Willigendael, Maarten A Lijkwan, Friedo W Dekker, Chava L Ramspek, Michiel W de Haan, Çaĝdaş Ünlü, Boudewijn DC Heggen, Koen E A van der Bogt, Marc H Hemmelder, Mickaël J C Hiligsmann, Magda M van Loon, Joris I Rotmans, Jan H M Tordoir, Geert Willem H Schurink, Maarten G J Snoeijs, Marijke J Molegraaf, Philippe WM Cuypers, Denise Nio, Cora H Arts, Jacobien C Verhave, Goos D Laverman, Aron S Bode, Marcel C Weijmer, Bas Govaert, Aaltje Y Adema, Gijs MJM Welten, Michel MPJ Reijnen, Marc JH Groeneveld, Hans S Brink, Jeroen B van der Net, Arno Kuijper, Hilde PE Peters, Roos C van Nieuwenhuizen, Rombout R Kruse, Yvonne C Schrama, Karina A de Groot, Karima Farhat, Vascular Surgery, Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: Carim - B06 Imaging, Interne Geneeskunde, RS: Carim - V02 Hypertension and target organ damage, RS: CAPHRI - R2 - Creating Value-Based Health Care, Health Services Research, MUMC+: MA Med Staf Artsass Vaatchirurgie (9), RS: Carim - V03 Regenerative and reconstructive medicine vascular disease, MUMC+: MA Med Staf Spec Vaatchirurgie (9), and MUMC+: MA Vaatchirurgie CVC (3)
- Subjects
RISK ,OUTCOMES ,FISTULAS ,General Medicine ,adult nephrology ,vascular surgery ,DIALYSIS PATIENTS ,end-stage renal failure ,MULTIPLE IMPUTATION ,Clinical Protocols ,Renal Dialysis ,Arteriovenous Fistula ,RELIABILITY ,VASCULAR ACCESS ,Central Venous Catheters ,Humans ,Multicenter Studies as Topic ,Medicine ,dialysis ,ELDERLY-PATIENTS ,Aged ,Randomized Controlled Trials as Topic - Abstract
IntroductionCurrent 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 analysisOASIS 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 disseminationBecause 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.Trial registration numberNL7933.Protocol version and dateV.5, 25 February 2021.
- Published
- 2022