Albumin administration in septic shock-Protocol for post-hoc analyses of data from a multicentre RCT

Tine Sylvest Meyhoff*, Anders Granholm, Peter Buhl Hjortrup, Praleene Sivapalan, Theis Lange, Jon Henrik Laake, Maria Cronhjort, Stephan M Jakob, Maurizio Cecconi, Marek Nalos, Marlies Ostermann, Manu L N G Malbrain, Morten Hylander Møller, Anders Perner

*Corresponding author for this work
2 Citations (Scopus)

Abstract

BACKGROUND: Intravenous (IV) albumin is suggested for patients with septic shock who have received large amounts of IV crystalloids; a conditional recommendation based on moderate certainty of evidence. Clinical variation in the administration of IV albumin in septic shock may exist according to patient characteristics and location.

METHODS: This is a protocol and statistical analysis plan for a post-hoc secondary study of the Conservative versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care (CLASSIC) RCT of 1554 adult ICU patients with septic shock. We will assess if specific baseline characteristics or trial site are associated with the administration of IV albumin during ICU stay using Cox models with competing events. All models will be adjusted for the treatment allocation in CLASSIC (restrictive vs. standard IV fluid), and all analyses will consider competing events (death, ICU discharge and loss-to-follow-up). We will present results as hazard ratios with 95% confidence intervals and p-values for the associations of baseline characteristics or site with IV albumin administration. Between-group differences (interactions) will be assessed using p-values from likelihood ratio tests. All results will be considered exploratory only.

DISCUSSION: This secondary study of the CLASSIC RCT may yield important insight into potential practice variation in the administration of albumin in septic shock.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Volume67
Issue number8
Pages (from-to)1128-1136
Number of pages9
ISSN0001-5172
DOIs
Publication statusPublished - Sept 2023

Keywords

  • Adult
  • Albumins/therapeutic use
  • Critical Care
  • Fluid Therapy/methods
  • Humans
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Research Design
  • Shock, Septic/drug therapy

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