Resuscitation With Vitamin C, Hydrocortisone, and Thiamin in Children With Septic Shock: A Multicenter Randomized

Luregn J Schlapbach1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16, Sainath Raman1,2, David Buckley4

  • 1Child Health Research Centre, The University of Queensland, Brisbane, QLD, Australia.

Insights

This pilot study found that administering vitamin C, hydrocortisone, and thiamin to pediatric intensive care unit patients with septic shock was feasible. Further research is needed to determine the intervention

Area of Science:

  • Pediatric critical care medicine
  • Septic shock management
  • Adjunctive therapies

Background:

  • Limited randomized controlled trial (RCT) data exists for adjunctive vitamin C, hydrocortisone, and thiamin in pediatric septic shock.
  • Previous studies in adults suggest potential benefits, necessitating pediatric investigation.
  • Septic shock in children requires effective and safe treatment strategies.

Purpose of the Study:

  • To assess the feasibility of administering vitamin C, hydrocortisone, and thiamin to pediatric intensive care unit (PICU) patients with septic shock.
  • To explore the association between this adjunctive therapy and improved survival free of organ dysfunction.
  • To inform the design of a larger, definitive randomized controlled trial.

Main Methods:

  • An open-label, parallel, pilot randomized controlled trial (RCT) was conducted across six PICUs in Australia and New Zealand.
  • Eligible patients (28 days to 18 years) with septic shock requiring vasoactive drugs were randomized (1:1) to receive either the intervention or standard care.
  • The primary endpoint was feasibility, with secondary clinical endpoints including survival free of organ dysfunction, shock reversal, and intervention efficacy proxies.

Main Results:

  • Feasibility was demonstrated, with 78% of eligible patients consenting and 91% of approached parents providing consent.
  • Median survival free of organ dysfunction was comparable between the intervention (20.0 days) and standard care (21.0 days) groups.
  • No significant difference was observed in shock reversal times between the groups, though the intervention group showed a trend towards faster resolution.

Conclusions:

  • The adjunctive therapy protocol involving high-dose vitamin C, hydrocortisone, and thiamin is feasible in children with septic shock requiring vasopressors.
  • The study provides valuable data for refining the protocol for a larger, more robust RCT.
  • Further investigation is warranted to definitively establish the efficacy and optimal use of this combination therapy in pediatric septic shock.
Abstract

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