Sepsis & infection

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

Acta Anaesthesiol ScandPublished Protocol and statistical analysis plan for a post-hoc secondary analysis of the CLASSIC randomised trial

Study context

Population
Adult ICU patients with septic shock in the CLASSIC RCTCLASSIC RCT
Participants
1,554 patients
Primary endpoint
Association of baseline characteristics or trial site with IV albumin administration during ICU stay (Cox models with competing events)
Methodological detailsexploratory, multicentre, Models adjusted for CLASSIC allocation (restrictive vs standard intravenous (IV) fluid); competing events death, ICU discharge, loss-to-follow-up, Results as HR with 95% CI; interactions by likelihood ratio tests; all results exploratory
  • Exploratory
  • Multicentre
  • Models adjusted for CLASSIC allocation (restrictive vs standard IV fluid); competing events death, ICU discharge, loss-to-follow-up
  • Results as HR with 95% CI; interactions by likelihood ratio tests; all results exploratory

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Albumin administration in septic shock—Protocol for post‐hoc analyses of data from a multicentre RCT. Acta Anaesthesiol Scand. Published 29 May 2023. doi:10.1111/aas.14280

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