TY - JOUR

T1 - Albumin administration in septic shock-Protocol for post-hoc analyses of data from a multicentre RCT

AU - Meyhoff, Tine Sylvest

AU - Granholm, Anders

AU - Hjortrup, Peter Buhl

AU - Sivapalan, Praleene

AU - Lange, Theis

AU - Laake, Jon Henrik

AU - Cronhjort, Maria

AU - Jakob, Stephan M

AU - Cecconi, Maurizio

AU - Nalos, Marek

AU - Ostermann, Marlies

AU - Malbrain, Manu L N G

AU - Møller, Morten Hylander

AU - Perner, Anders

N1 - © 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

U2 - 10.1111/aas.14280

DO - 10.1111/aas.14280

M3 - Journal article

C2 - 37246841

VL - 67

SP - 1128

EP - 1136

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 8

ER -