干旱区生态环境知识资源中心(Arid): Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial

Arid

DOI	10.1136/bmjopen-2021-053108
	Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial
	Heggen, Boudewijn D. C.; Ramspek, Chava L.; van der Bogt, Koen E. A.; de Haan, Michiel W.; Hemmelder, Marc H.; Hiligsmann, Mickael J. C.; van Loon, Magda M.; Rotmans, Joris, I; Tordoir, Jan H. M.; Dekker, Friedo W.; Schurink, Geert Willem H.; Snoeijs, Maarten G. J.
通讯作者	Heggen, BDC
来源期刊	BMJ OPEN
ISSN	2044-6055
出版年	2022
卷号	12 期号:2
英文摘要	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.
英文关键词	vascular surgery vascular surgery dialysis end-stage renal failure adult nephrology
类型	Article
语种	英语
开放获取类型	gold, Green Published
收录类别	SCI-E
WOS记录号	WOS:000754022100003
WOS关键词	VASCULAR ACCESS ; MULTIPLE IMPUTATION ; DIALYSIS PATIENTS ; ELDERLY-PATIENTS ; OUTCOMES ; RELIABILITY ; FISTULAS ; RISK
WOS类目	Medicine, General & Internal
WOS研究方向	General & Internal Medicine
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/376366
推荐引用方式 GB/T 7714	Heggen, Boudewijn D. C.,Ramspek, Chava L.,van der Bogt, Koen E. A.,et al. Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial[J],2022,12(2).
APA	Heggen, Boudewijn D. C..,Ramspek, Chava L..,van der Bogt, Koen E. A..,de Haan, Michiel W..,Hemmelder, Marc H..,...&Snoeijs, Maarten G. J..(2022).Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial.BMJ OPEN,12(2).
MLA	Heggen, Boudewijn D. C.,et al."Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial".BMJ OPEN 12.2(2022).