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Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial

Authors: D. Stelzer; H. Binder; M. Glattacker; E. Graf; M. Hahn; M. Hollenbeck; K. Kaier; +7 Authors

Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial

Abstract

Abstract Background Early identification of patients with chronic kidney disease (CKD) and advancing kidney insufficiency, followed by specialist care, can decelerate the progression of the disease. However, awareness of the importance and possible consequences of kidney insufficiency is low among doctors and patients. Since kidney insufficiency can be asymptomatic even in higher stages, it is often not even known to those belonging to risk groups. This study aims to clarify whether, for hospitalised patients with advanced chronic kidney disease, a risk-based appointment with a nephrology specialist reduces disease progression. Methods The target population of the study is hospitalised CKD patients with an increased risk of end-stage renal disease (ESRD), more specifically with an ESRD risk of at least 9% in the next 5 years. This risk is estimated by the internationally validated Kidney Failure Risk Equation (KFRE). The intervention consists of a specific appointment with a nephrology specialist after the hospital stay, while control patients are discharged from the hospital as usual. Eight medical centres include participants according to a stepped-wedge design, with randomised sequential centre-wise crossover from recruiting patients into the control group to recruitment to the intervention. The estimated glomerular filtration rate (eGFR) is measured for each patient during the hospital stay and after 12 months within the regular care by the general practitioner. The difference in the change of the eGFR over this period is compared between the intervention and control groups and considered the primary endpoint. Discussion This study is designed to evaluate the effect of risk-based appointments with nephrology specialists for hospitalised CKD patients with an increased risk of end-stage renal disease. If the intervention is proven to be beneficial, it may be implemented in routine care. Limitations will be examined and discussed. The evaluation will include further endpoints such as non-guideline-compliant medication, economic considerations and interviews with contributing physicians to assess the acceptance and feasibility of the intervention. Trial registration German Clinical Trials Register DRKS00029691. Registered on 12 September 2022.

Keywords

Medicine (General), Time Factors, Cluster-randomised trial (CRT), Medizin, 610, Chronic kidney disease (CKD), Risk Assessment, Study Protocol, Appointments and Schedules, R5-920, Renal Dialysis, Risk Factors, Humans, Multicenter Studies as Topic, Stepped-wedge design, Cluster-randomised trial (CRT) ; Kidney failure risk equation (KFRE) ; Disease Progression [MeSH] ; Renal Insufficiency, Chronic/diagnosis [MeSH] ; Hospitalization [MeSH] ; Risk Assessment [MeSH] ; Study Protocol ; Humans [MeSH] ; Treatment Outcome [MeSH] ; Appointments and Schedules [MeSH] ; Risk Factors [MeSH] ; Multicenter Studies as Topic [MeSH] ; Time Factors [MeSH] ; End-stage renal disease (ESRD) ; Randomized Controlled Trials as Topic [MeSH] ; Glomerular Filtration Rate [MeSH] ; Stepped-wedge design ; Chronic kidney disease (CKD) ; Renal Insufficiency, Chronic/therapy [MeSH] ; Renal Dialysis [MeSH] ; Kidney Failure, Chronic/therapy [MeSH] ; Estimated glomerular filtration rate (eGFR), Renal Insufficiency, Chronic, Randomized Controlled Trials as Topic, End-stage renal disease (ESRD), Hospitalization, Treatment Outcome, Disease Progression, Estimated glomerular filtration rate (eGFR), Kidney Failure, Chronic, Kidney failure risk equation (KFRE), Glomerular Filtration Rate

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
1
Average
Top 10%
Average
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