Protocolised early de-resuscitation in septic shock (REDUCE): protocol for a randomised controlled multicentre feasibility trial - Messmer, A.; Pietsch, U.; Siegemund, M.; Buehler, P.; Waskowski, J.; Muller, M.; Uehlinger, D. E.; Hollinger, A.; Filipovic, M.; Berger, D.; Schefold, J. C.; Pfortmueller, C. A. (BMJ Open, 2023)
BACKGROUND: Fluid overload is associated with excess mortality in septic shock. Current approaches to reduce fluid overload include restrictive administration of fluid or active removal of accumulated fluid. However, evidence on active fluid removal is scarce. The aim of this study is to assess the efficacy and feasibility of an early de-resuscitation protocol in patients with septic shock. METHODS: All patients admitted to the intensive care unit (ICU) with a septic shock are screened, and eligible patients will be randomised in a 1:1 ratio to intervention or standard of care. INTERVENTION: Fluid management will be performed according to the REDUCE protocol, where resuscitation fluid will be restricted to patients showing signs of poor tissue perfusion. After the lactate has peaked, the patient is deemed stable and assessed for active de-resuscitation (signs of fluid overload). The primary objective of this study is the proportion of patients with a negative cumulative fluid balance at day 3 after ICU. Secondary objectives are cumulative fluid balances throughout the ICU stay, number of patients with fluid overload, feasibility and safety outcomes and patient-centred outcomes. The primary outcome will be assessed by a logistic regression model adjusting for the stratification variables (trial site and chronic renal failure) in the intention-to-treat population. ETHICS AND DISSEMINATION: The study was approved by the respective ethical committees (No 2020-02197). The results of the REDUCE trial will be published in an international peer-reviewed medical journal regardless of the results. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04931485.
Keywords: journalArticle; *Kidney Failure, Chronic; *Shock, Septic/therapy; Adult intensive & critical care; Anandic Medical Systems, Pan Gas AG Healthcare, Bracco, Hamilton Medical AG,; Astellas, AstraZeneca, CSL Behring, Novartis, Covidien, Phagenesis, Cytel and; Dialysis; Feasibility Studies; Fresenius Kabi, Getinge Group Maquet AG, Drager AG, Teleflex Medical GmbH,; GlaxoSmithKline, Merck Sharp and Dohme AG, Eli Lilly and Company, Baxter,; Humans; INTENSIVE & CRITICAL CARE; Inselspital (AM, JW, DB, CAP and JCS) reports grants from Orion Pharma, Abbott; Lactic Acid; Multicenter Studies as Topic; Nutrition International, B. Braun Medical AG, CSEM AG, Edwards Lifesciences; Nycomed outside the project. The money was paid into departmental funds; Randomized Controlled Trials as Topic; Research AG, Nestle, Pierre Fabre Pharma AG, Pfizer, Bard Medica S.A., Abbott AG,; Resuscitation; Services GmbH, Kenta Biotech Ltd, Maquet Critical Care AB, Omnicare Clinical; no; personal financial gain applied. All other authors have nothing to disclose