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Trials
Trials
Trials
1745-6215
BioMed Central London

8394
10.1186/s13063-024-08394-1
Update
Update to the study protocol: minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): a multicentre, stepped-wedge, cluster-randomised controlled trial
Stelzer D. dominikus.stelzer@uniklinik-freiburg.de

1
Binder H. 1
Glattacker M. 2
Graf E. 1
Hahn M. 6
Hollenbeck M. 5
Kaier K. 1
Kowall B. 7
Kuklik N. 78
Metzner G. 2
Mueller N. 5
Seiler L. 34
Stolpe S. 7
Blume C. 34
1 https://ror.org/0245cg223 grid.5963.9 0000 0004 0491 7203 Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Stefan-Meier-Str. 26, Freiburg, 79104 Germany
2 https://ror.org/0245cg223 grid.5963.9 0000 0004 0491 7203 Section 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
3 https://ror.org/0304hq317 grid.9122.8 0000 0001 2163 2777 Institute of Technical Chemistry, Leibniz University Hanover, Callinstraße 5, Hannover, 30167 Germany
4 grid.490904.0 0000 0005 0272 0690 KfH Foundation for Preventive Medicine, Martin-Behaim-Straße 20, Neu-Isenburg, 63263 Germany
5 https://ror.org/04mz5ra38 grid.5718.b 0000 0001 2187 5445 Knappschaftskrankenhaus Bottrop GmbH, Academic Teaching Hospital of the University of Duisburg-Essen, Osterfelder Straße 157, Bottrop, 46242 Germany
6 Knappschafts-Kliniken Service GmbH (KKSG), In der Schornau 23-25, Bochum, 44892 Germany
7 grid.410718.b 0000 0001 0262 7331 Institute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Hufelandstraße 55, Essen, 45147 Germany
8 https://ror.org/02na8dn90 grid.410718.b 0000 0001 0262 7331 Centre for Clinical Trials Essen, University Hospital Essen, Hufelandstraße 55, Essen, 45122 Germany
4 9 2024
4 9 2024
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© The Author(s) 2024
2024
https://creativecommons.org/licenses/by/4.0/ Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
This document reports a brief update to the previously published protocol of the MinDial study.

Trial registration German Clinical Trials Register DRKS00029691. Registered on 12 Sept. 2022, https://drks.de/search/en/trial/DRKS00029691.

Keywords

Chronic kidney disease (CKD)
Kidney failure risk equation (KFRE)
End-stage renal disease (ESRD)
Estimated glomerular filtration rate (eGFR)
Stepped-wedge design
Cluster-randomised trial (CRT)
Universitätsklinikum Freiburg (8975)Open Access funding enabled and organized by Projekt DEAL.

issue-copyright-statement© BioMed Central Ltd., part of Springer Nature 2024
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pmcUpdate to the study protocol

The protocol of the MinDial study was previously published in Trials [1]. As stated in the subsection “Baseline data” of section “Participant timeline {13}”, the MinDial trial proceeds as follows: “To document serum creatinine, KFRE score, blood pressure and HbA1c in the eCRF, all values are taken at a time interval around the date when the KFRE score is ≥ 15% (date of laboratory determination before 20 June 2023) or ≥ 9% (since 20 June 2023) for the first time in the current case.”

In June 2024, the study protocol was amended to be more specific on which of the measurements of the kidney failure risk equation (KFRE) score, serum creatinine and estimated glomerular filtration rate (eGFR) should be documented in the electronic case report form (eCRF), and to pre-specify the measurement designated as baseline. Accordingly, we would like to add the following as a supplement to the above paragraph:

“To be more specific, the KFRE score, serum creatinine and eGFR are documented at several time points:KFRE score:measurement on the day of the current hospital stay on a peripheral ward on which the KFRE score is ≥ 15% or ≥ 9%, respectively, for the first time;

measurement closest to the inclusion date (baseline);

measurement closest to discharge;

Serum creatinine: measurements on the same days as with the KFRE score;

eGFR: measurements on the same days as with the KFRE score.

The measurements closest to the inclusion date are considered as the baseline and used for the evaluation.”

Apart from this, the study protocol remains unchanged.

Abbreviations

eCRF Electronic case report form

eGFR Estimated glomerular filtration rate

KFRE Kidney failure risk equation

Acknowledgements

Not applicable.

Authors’ contributions

DS prepared this update document. All authors read and approved the final version.

Funding

Open Access funding enabled and organized by Projekt DEAL. The MinDial study is funded by the Innovation Fund of the Federal Joint Committee (G-BA) in Germany, grant number 01NVF20028. Open Access funding enabled and organized by Projekt DEAL.

Availability of data and materials

Not applicable.

Declarations

Ethics approval and consent to participate

Ethics approval was granted on 27 June 2022 by the “Ethik Kommission der Aerztekammer Westfalen-Lippe und der Westfaelischen Wilhelms-Universitaet”, located in Muenster/Westfalen (2022–257-f-S). Furthermore, four amendments were made by the study team and approved by the ethics commission. Data protection documents were prepared by a legal adviser at Knappschaftskliniken and the responsible data protection commissioner of each participating clinic agreed to the data protection documents. Written, informed consent to participate will be obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they do not have competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Reference

1. Stelzer D Binder H Glattacker M Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial Trials 2024 25 368 10.1186/s13063-024-08182-x 38849916
Stelzer D, Binder H, Glattacker M, et al. Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial. Trials. 2024;25:368. 10.1186/s13063-024-08182-x.38849916 10.1186/s13063-024-08182-x
