Early resuscitation in paediatric sepsis

A randomised controlled pilot study

Grant ID: EMPJ-207R29-2018

Project Summary

Sepsis is a leading cause of death and disability in children, globally accounting for more than one million childhood deaths per year. Recommended sepsis treatment currently consists of intravenous antibiotics and aggressive fluid boluses followed by inotropes and consideration for intravenous steroids. However, the evidence for interventions other than antibiotics is limited and aggressive fluid administration may be associated with harm. Therefore, fluid-sparing algorithms using early inotropes to treat shock have been proposed. Another strategy to hasten shock resolution consists in intravenous steroids, alone or in combination with thiamine and vitamin C, postulated to support metabolic dysfunction in recent studies.

In this project, the research team is conducting a randomised controlled pilot trial in children presenting with septic shock. They are assessing the feasibility of a fluid-sparing algorithm using early inotropes and early intravenous administration of Vitamin C, Thiamine and Hydrocortisone and the impact on survival free of organ dysfunction.

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Leveraged Funds

- NHMRC: $1,305,173 [Gibbons K, (2022) Early Resuscitation of Pediatric Sepsis.]
- Wolfermann-Naegeli Foundation (Zurich, Switzerland): $200,000 [Schlapbach L. (2022) Early Resuscitation of Pediatric Sepsis.]
- Financial Markets for Children: $159,496 [Schlapbach L., Harley A (2019) Acute Resuscitation In Paediatric SEpsis (ARISE-KIDS) - a randomised controlled trial to reduce morbidity and mortality due to sepsis in children. ]
- SERTA Queensland Children`s Hospital: $20,000 [Harley A, Schlapbach L. (2019) Early Resuscitation in Paediatric Sepsis Using Inotropes and Metabolic Support – A Randomized Controlled Pilot Platform Study. ]
- Gold Coast Health and Gold Coast Hospital Foundation: $99,860 [Bell C, Harley A, King M, Schlapbach L, George S, Keijzers G, Gibbons K, Lister P, Bellomo R, Schibler A. (2018). Rapid resuscitation in paediatric sepsis: A randomised controlled study to reduce morbidity and mortality due to sepsis in children. ]

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Dissemination

Publications:

- Harley, A., George, S., Phillips, N., King, M., Long, D., Keijzers, G., Lister, P., Raman, S., Bellomo, R., Gibbons, K. and Schlapbach, L.J., 2024. Resuscitation With Early Adrenaline Infusion for Children With Septic Shock: A Randomized Pilot Trial. Pediatric Critical Care Medicine, 25(2), pp.106-117.

- Schlapbach, L.J., Raman, S., Buckley, D., George, S., King, M., Ridolfi, R., Harley, A., Cree, M., Long, D., Erickson, S. and Singh, P., 2024. Resuscitation With Vitamin C, Hydrocortisone, and Thiamin in Children With Septic Shock: A Multicenter Randomized Pilot Study. Pediatric Critical Care Medicine, 25(2), pp.159-170.

- Harley, A., George, S., King, M., Phillips, N., Keijzers, G., Long, D., Gibbons, K., Bellomo, R. and Schlapbach, L.J., 2021. Early resuscitation in paediatric sepsis using inotropes–a Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): study protocol and analysis plan. Frontiers in pediatrics, p.452.

- Schlapbach, L.J., Gibbons, K., Ridolfi, R., Harley, A., Cree, M., Long, D., Buckley, D., Erickson, S., Festa, M., George, S., King, M., Singh, P., and Bellomo, R., 2021. Resuscitation in paediatric sepsis using metabolic resuscitation–a Randomized Controlled Pilot Study in the Paediatric Intensive Care Unit (RESPOND PICU): study protocol and analysis plan. Frontiers in pediatrics, 9, p.663435.

Presentation:

- Schlapbach, L., Resuscitation With Vitamin C, Hydrocortisone, and Thiamine in Children With Septic Shock: A Multicenter, Randomized Pilot Study and the Corresponding Observational Study of Serum Levels of Vitamin C and Thiamine in Children With Suspected Sepsis: A Prospective Observational Cohort Study (PCCM) (selected as a late breaker oral presentation). Critical Care Congress 2024, Phoenix, Arizona, in 19-23 January 2024.

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Video/Presentations

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