• 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, MalbrainManu L N GMLNGDepartment of Intensive Care Medicine, University Hospital Brussels (UZB), Jette, Belgium.First Department of Anaesthesiology and Intensive Therapy, Medical University of Lublin, Lublin, Poland., MøllerMorten HylanderMHDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark., and Anders Perner.
• Department of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
• Acta Anaesthesiol Scand. 2023 Sep 1; 67 (8): 112811361128-1136.

BackgroundIntravenous (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.MethodsThis 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.DiscussionThis secondary study of the CLASSIC RCT may yield important insight into potential practice variation in the administration of albumin in septic shock.© 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

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