Evidence map›Paper›PMID 38849916›Full record

ArticleTrials2024

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

D Stelzer, H Binder, M Glattacker, E Graf, M Hahn, M Hollenbeck, K Kaier, B Kowall, N Kuklik, G Metzner and 4 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

D StelzerInstitute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Str. 26, Freiburg, 79104, Germany. dominikus.stelzer@uniklinik-freiburg.de.ORCID http://orcid.org/0000-0001-7970-6388
H BinderInstitute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Str. 26, Freiburg, 79104, Germany.
M GlattackerSection of Health Care Research and Rehabilitation Research, Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Hugstetter Straße 49, Freiburg, 79106, Germany.
E GrafInstitute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Str. 26, Freiburg, 79104, Germany.
M HahnKnappschafts-Kliniken Service GmbH (KKSG), In der Schornau 23-25, Bochum, 44892, Germany.
M HollenbeckKnappschaftskrankenhaus Bottrop GmbH, Academic Teaching Hospital of the University of Duisburg-Essen, Osterfelder Straße 157, Bottrop, 46242, Germany.
K KaierInstitute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Str. 26, Freiburg, 79104, Germany.
B KowallInstitute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Hufelandstraße 55, Essen, 45147, Germany.
N KuklikInstitute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Hufelandstraße 55, Essen, 45147, Germany.
G MetznerSection of Health Care Research and Rehabilitation Research, Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Hugstetter Straße 49, Freiburg, 79106, Germany.
N MuellerKnappschaftskrankenhaus Bottrop GmbH, Academic Teaching Hospital of the University of Duisburg-Essen, Osterfelder Straße 157, Bottrop, 46242, Germany.
L SeilerInstitute of Technical Chemistry, Leibniz University Hannover, Callinstraße 5, Hannover, 30167, Germany.
S StolpeInstitute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Hufelandstraße 55, Essen, 45147, Germany.
C BlumeInstitute of Technical Chemistry, Leibniz University Hannover, Callinstraße 5, Hannover, 30167, Germany.

Funding

Innovation Fund of the Federal Joint Committee (G-BA), Germany 01NVF20028
6 · The paper itself

Abstract

backgroundEarly 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.

methodsThe 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 registrationGerman Clinical Trials Register DRKS00029691 . Registered on 12 September 2022.

Indexed as

Disease ProgressionGlomerular Filtration RateKidney Failure, ChronicMulticenter Studies as TopicRandomized Controlled Trials as TopicRenal DialysisRenal Insufficiency, ChronicAppointments and SchedulesHospitalizationHumansRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeChronic kidney disease (CKD)Cluster-randomised trial (CRT)End-stage renal disease (ESRD)Estimated glomerular filtration rate (eGFR)Kidney failure risk equation (KFRE)Stepped-wedge design

Identifiers

PMID38849916
PMCPMC11157728

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.