Intervention With Concentrated Albumin for Undifferentiated Sepsis in the Emergency Department (ICARUS-ED): A Pilot Randomized Controlled Trial - 23/01/25

Doi : 10.1016/j.annemergmed.2024.12.016

Julian M. Williams, MBBS, PhD ^a,^b,^c,^⁎ , Jaimi H. Greenslade, MSc, PhD ^a,^c, Angela Z. Hills, BA, BNurs ^a, Mercedes T. Ray, BNurs ^a
^a Emergency and Trauma Center, Royal Brisbane and Women’s Hospital, Brisbane, Australia
^b Faculty of Medicine, University of Queensland, Brisbane, Australia
^c Faculty of Health, Queensland University of Technology, Brisbane, Australia

^∗Corresponding author.

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Thursday 23 January 2025

Abstract

Study objectives

Concentrated albumin early in sepsis resuscitation remains largely unexplored. Objectives were to determine 1) feasibility of early intervention with concentrated albumin in emergency department (ED) patients with suspected infection and hypoperfusion and 2) whether early albumin therapy improves outcomes.

Methods

ED patients with suspected infection and hypoperfusion (systolic blood pressure [SBP]<90 mmHg or lactate ≥4.0 mmol/L) were randomized to receive either 400 mL 20% albumin over 4 hours or no albumin. All patients were treated with crystalloids, antibiotics, and other therapies at the treating team's discretion. Primary outcome was SBP at 24 hours; secondary outcomes included SBP at 6 hours, fluid and organ support requirements, organ dysfunction, and mortality. Quantile and logistic regressions were used to calculate differences (and 95% CI) between study groups.

Results

Compliance with study protocol was more than 95%, and infection was confirmed in 95% of the 464 study patients enrolled. SBP at 24 hours did not differ between intervention (110.5 mmHg) and standard care arms (110 mmHg). In patients treated with albumin, SBP was higher at 6 hours, less total fluid was infused at 72 hours, fewer patients required vasopressor therapy at 24 and 72 hours, and organ function was improved. Mortality was not significantly different.

Conclusions

Early identification, trial enrollment, and intervention in ED patients with sepsis is feasible. In this pilot study, concentrated albumin given early in resuscitation did not improve SBP at 24 hours. Albumin was associated with less total fluid and vasopressor requirements and improved organ dysfunction. A multicenter study is indicated.

Le texte complet de cet article est disponible en PDF.

Keywords : Sepsis, Albumin, Early sepsis resuscitation

Plan

Introduction

Background

Importance

Goals of This Investigation

Methods

Study Design and Setting

Selection of Participants

Sample Size Determination

Results

Characteristics of Study Subjects

	Please see page XX for the Editor’s Capsule Summary of this article.
	Supervising editor: Alan E. Jones, MD. Specific detailed information about possible conflicts of interest for individual editors is available at editors.
	Author contributions: JW and JG jointly designed the study and wrote the manuscript. JG conducted statistical analyses. AZH and MR helped with study design and practical execution, collected data, and critically reviewed the manuscript. JW takes overall responsibility for the study as a whole.
	Data sharing statement: Partial or complete datasets and data dictionary are available from February 2025 upon request to Dr. Williams at julian.williams@health.qld.gov.au, to investigators who provide an IRB letter of approval.
	All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
	Funding and support: By Annals’ policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). The authors have stated that no such relationships exist. This research was supported by a competitive grant from the Emergency Medicine Foundation (emergencyfoundation.org.au). All therapeutic resources, including albumin were supplied by Queensland Health.
	Trial registration number: ACTRN 12621000036819