System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Clinical Trial Protocol Epublish

PubMed: 40473280 DOI: 10.1136/bmjopen-2024-097361

Multicentre pragmatic embedded stepped wedge cluster randomised trial comparing glucose 5% with sodium chloride 0.9% as the default drug diluent in the ICU: the sweet-water trial protocol.

BMJ Open 15(6):e097361

Authors: Jan-Hendrik Bernhard Hardenberg, Ricarda Merle Hinz, Mareen Pigorsch, Alexander Uhrig, Holger Müller-Redetzky, Jens Nee, Tim Schroeder, Martin Witzenrath, Ulrike Trost, Daniel Zickler, Oliver Hunsicker, Bjoern Weiss, Steffen Weber-Carstens, Claudia Spies, Björn Tampe, Rainer Borgstedt, Mariam Abu-Tair, Alexander Zarbock, Christian Strauß, Heiko Schenk, Uta Hildebrand, Dario von Wedel, Felix Balzer, Kai-Uwe Eckardt, Philipp Enghard

Affiliations

  • Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • Department of Nephrology and Medical Intensive Care, St Joseph Krankenhaus Berlin-Tempelhof, Berlin, Germany.
  • Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • Universitätsmedizin Göttingen, Gottingen, Germany.
  • Department of Anaesthesiology, Intensive Care, Emergency Medicine, Transfusion Medicine and Pain Therapy, University Medical Center OWL Bielefeld University, Campus Bielefeld-Bethel, Bielefeld, Germany.
  • Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany.
  • Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany.
  • Institute of Medical Informatics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • German Rheumatism Research Center Berlin, Berlin, Germany.

Abstract

INTRODUCTION

Hypernatraemia, defined as a plasma sodium concentration >145 mmol/L, is a frequent complication in critically ill patients treated in the intensive care unit (ICU) (= ICU-acquired hypernatraemia), with reported prevalence ranging from 4% to 26%. Hypernatraemia adversely affects various physiological functions and is associated with delirium, prolonged length of stay and increased ICU and post-discharge mortality. The sodium load from intravenous drug diluents significantly contributes to ICU-acquired hypernatraemia, with drug infusions comprising about 30% of the daily fluid volume of an average ICU patient. This study aims to investigate if using glucose 5% solution as the default drug diluent, instead of sodium chloride 0.9%, can reduce the prevalence of ICU-acquired hypernatraemia and improve patient outcomes.

METHODS AND ANALYSIS

To test the effectiveness of glucose 5% solution as the default drug diluent, we will conduct a multicentre, pragmatic, embedded, open-label, stepped-wedge, cluster-randomised trial. The study will include twelve clusters (ICUs and one intermediate care unit) across six hospitals in Germany, with a projected total sample size of 4485 patients. In line with the stepped-wedge cluster-randomised design, one ICU will transition every 4 weeks, in a randomised sequence, from using sodium chloride 0.9% as the default drug diluent to glucose 5%.The primary endpoint is the prevalence of hypernatraemia >150 mmol/L through day 28. The number of days alive and free of the ICU through day 28 will be tested hierarchically as a key secondary endpoint. Other exploratory endpoints include ICU mortality, ICU-free days, hospital-free days and other clinical outcomes. The primary endpoint will be analysed using a logistic mixed-effects model.

ETHICS AND DISSEMINATION

The trial was approved by the Charité-Universitätsmedizin Berlin Ethics Board and by the ethics board of each enrolled hospital. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

TRIAL REGISTRATION NUMBER

The trial protocol was registered with the German Clinical Trials Register on 21 June 2024 prior to initiation of patient enrolment (DRKS00033397).

MeSH

Clinical Protocols, Mortality, Pharmaceutical Preparations, Solutions, Prevalence, Intensive Care Units