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Research Article: REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: study protocol for a pilot randomised controlled trial (REDUCE-1)

Date Published: 2023-11-29

Abstract:
Introduction Intravenous fluid therapy is the most common intervention in critically ill children. There is an increasing body of evidence questioning the safety of high-volume intravenous fluid administration in these patients. To date, the optimal fluid management strategy remains unclear. We aimed to test the feasibility of a pragmatic randomised controlled trial comparing a restrictive with a standard (liberal) fluid management strategy in critically ill children. Methods and analysis Multicentre, binational pilot, randomised, controlled, open-label, pragmatic trial. Patients <18 years admitted to paediatric intensive care unit and mechanically ventilated at the time of screening are eligible. Patients with tumour lysis syndrome, diabetic ketoacidosis or postorgan transplant are excluded. Interventions: 1:1 random assignment of 154 individual patients into two groups—restrictive versus standard, liberal, fluid strategy—stratified by primary diagnosis (cardiac/non-cardiac). The intervention consists of a restrictive fluid bundle, including lower maintenance fluid allowance, limiting fluid boluses, reducing volumes of drug delivery and initiating diuretics or peritoneal dialysis earlier. The intervention is applied for 48 hours postrandomisation or until discharge (whichever is earlier). Endpoints: The number of patients recruited per month and proportion of recruited to eligible patients are feasibility endpoints. New-onset acute kidney injury and the incidence of clinically relevant central venous thrombosis are safety endpoints. Fluid balance at 48 hours after randomisation is the efficacy endpoint. Survival free of paediatric intensive care censored at 28 days is the clinical endpoint. Ethics and dissemination Ethics approval was gained from the Children’s Health Queensland Human Research Ethics Committee (HREC/21/QCHQ/77514, date: 1 September 2021), and University of Zurich (2021-02447, date: 17 March 2023). The trial is registered with the Australia New Zealand Clinical Trials Registry (ACTRN12621001311842). Open-access publication in high impact peer-reviewed journals will be sought. Modern information dissemination strategies will also be used including social media to disseminate the outcomes of the study. Trial registration number ACTRN12621001311842. Protocol version/date V5/23 May 2023.

Introduction:
Over 100?000 patients are admitted to paediatric intensive care units (PICUs) across the USA every year, and similar admission rates per population have been reported in other continents. 1 2 Intravenous fluid therapy (IVFT) remains the most common intervention in critically ill patients and includes both fluid boluses and maintenance fluids. 3 Maintenance intravenous fluid regimens, dating back to observational landmark studies in the 1950s, 4 have led to a clinical practice that favours wide use of fluid…

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