Abstract | BACKGROUND: METHODS: This is a single-centre, open-label randomized controlled trial with parallel 1:1:1 assignment into three groups: 0.9% sodium chloride, Plasma-Lyte 148, and Compound Sodium Lactate solutions for intravenous fluid therapy. The intervention includes both maintenance and bolus fluid therapy. Children aged < 16 years admitted to intensive care and receiving intravenous fluid therapy during the first 4 h of admission are eligible. The primary outcome measure is a ≥ 5mmol/L increase in serum chloride level within 48 h post-randomization. The enrolment target is 480 patients. The main analyses will be intention-to-treat. DISCUSSION: This study tests three types of intravenous fluid therapy in order to compare the risk of hyperchloremia associated with normal saline versus balanced solutions. This pragmatic study is thereby assessing the most common intervention in paediatric critical care. This is a single-centre open-label study with no blinding at the level of delivery of the intervention. Certain paediatric intensive care unit (PICU) patient groups such as those admitted with a cardiac condition or following a traumatic brain injury are excluded from this study. TRIAL REGISTRATION: The study has received ethical approval (HREC/19/QCHQ/53177: 06/06/2019). It is registered in the Australian New Zealand Clinical Trials Registry ( ACTRN12619001244190 ) from 9th September 2019. Recruitment commenced on 12th November 2019. The primary results manuscript will be published in a peer-reviewed journal.
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Authors | Sainath Raman, Andreas Schibler, Renate Le Marsney, Peter Trnka, Melanie Kennedy, Adrian Mattke, Kristen Gibbons, Luregn J Schlapbach |
Journal | Trials
(Trials)
Vol. 22
Issue 1
Pg. 427
(Jul 03 2021)
ISSN: 1745-6215 [Electronic] England |
PMID | 34217337
(Publication Type: Clinical Trial Protocol, Journal Article)
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Chemical References |
- Gluconates
- Plasma-lyte 148
- Magnesium Chloride
- Sodium Chloride
- Sodium Acetate
- Potassium Chloride
- Sodium Lactate
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Topics |
- Australia
- Child
- Fluid Therapy
- Gluconates
- Humans
- Intensive Care Units, Pediatric
- Magnesium Chloride
- Potassium Chloride
- Randomized Controlled Trials as Topic
- Sodium Acetate
- Sodium Chloride
- Sodium Lactate
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