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Published in: Trials 1/2020

Open Access 01-12-2020 | Community-Acquired Pneumonia | Study protocol

Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial—a trial protocol

Authors: Alexander Rombauts, Gabriela Abelenda-Alonso, Antonella Francesca Simonetti, Guillermo Verdejo, Yolanda Meije, Lucia Ortega, Mercedes Clemente, Jordi Niubó, Yolanda Ruiz, Carlota Gudiol, Cristian Tebé, Sebastian Videla, Jordi Carratalà

Published in: Trials | Issue 1/2020

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Abstract

Background

Community-acquired pneumonia (CAP) remains a leading cause of death worldwide, and hypoalbuminemia is associated with worse outcomes. However, it remains uncertain whether albumin administration could have any beneficial effects. We aim to assess whether the administration of albumin in hypoalbuminemic patients with CAP increases the proportion of clinically stable patients at day 5 compared with the standard of care alone.

Methods

This is a trial protocol for a superiority, non-blinded, multicenter, randomized, phase 3, interventional controlled clinical trial. The primary endpoint will be the proportion of clinical stable patients at day 5 (intention to treat), defined as those with stable vital signs for at least 24 h. The secondary endpoints will be time to clinical stability, duration of intravenous and total antibiotic treatment, length of hospital stay, intensive care unit admission, duration of mechanical ventilation and vasopressor treatment, adverse events, readmission within 30 days, and all-cause mortality. The trial has been approved by the Spanish Medicines and Healthcare Products Regulatory Agency. The investigators commit to publish the data in peer-reviewed journals within a year of the study completion date. Subjects will be recruited from three Spanish hospitals over a planned enrolment period of 2 years. A follow-up visit will be performed 1 month after discharge. We have estimated the need for a sample size of 360 patients at a two-sided 5% alpha-level with a power of 80% based on intention to treat. Eligible participants must be hospitalized, hypoalbuminemic (≤ 30 g/L), non-immunosuppressed, adults, and diagnosed with CAP. They will be randomly assigned (1:1) to receive standard care plus albumin (20 g in 100 mL) every 12 h for 4 days or standard care alone.

Discussion

If this randomized trial confirms the hypothesis, it should lead to a change in current clinical practice for the management of hypoalbuminemic patients with CAP.

Trial registration

European Clinical Trials Database (EudraCT) 2018-003117-18. Registered on 12 April 2019. ClinicalTrials.gov NCT04071041. Registered on 27 August 2019
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Metadata
Title
Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial—a trial protocol
Authors
Alexander Rombauts
Gabriela Abelenda-Alonso
Antonella Francesca Simonetti
Guillermo Verdejo
Yolanda Meije
Lucia Ortega
Mercedes Clemente
Jordi Niubó
Yolanda Ruiz
Carlota Gudiol
Cristian Tebé
Sebastian Videla
Jordi Carratalà
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04627-1

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