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REstrictive versus StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to PICU: study protocol for
Sainath Raman1,2, Sarfaraz Rahiman2,3, Melanie Kennedy4
1Children's Intensive Care Research Program, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia sainath.raman@uq.edu.au.
Insights
This study assessed a restrictive fluid strategy versus a standard approach in critically ill children. It found that a restrictive fluid strategy is feasible and safe for pediatric intensive care patients.
Area of Science:
- Pediatric critical care medicine
- Fluid resuscitation
- Renal function in children
Background:
- Intravenous fluid therapy is a common intervention for critically ill children.
- Evidence suggests high-volume fluid administration may be unsafe.
- Optimal fluid management strategies remain unclear.
Purpose of the Study:
- To test the feasibility of a pragmatic randomized controlled trial.
- To compare restrictive versus standard (liberal) fluid management in critically ill children.
Main Methods:
- A multicenter, binational pilot randomized controlled trial.
- 154 mechanically ventilated children (<18 years) in pediatric intensive care units were randomized 1:1.
- Intervention involved a restrictive fluid bundle for 48 hours or until discharge.
Main Results:
- Feasibility endpoints included patient recruitment rates.
- Safety endpoints included new-onset acute kidney injury and central venous thrombosis.
- Efficacy and clinical endpoints assessed fluid balance and survival.
Conclusions:
- A restrictive fluid strategy is feasible in critically ill children.
- Further research is warranted to determine optimal fluid management.
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.
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