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© The Author(s). 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

In cardiac surgery with cardiopulmonary bypass (CPB), large amounts of fluids are administered. CPB priming with crystalloid solution causes marked hemodilution and fluid extravasation. Colloid solutions may reduce fluid overload because they have a better volume expansion effect than crystalloids. The European Medicines Agency does not recommend the use of hydroxyethyl starch solutions (HES) due to harmful renal effects. Albumin solution does not impair blood coagulation but the findings on kidney function are conflicting. On the other hand, albumin may reduce endothelial glycocalyx destruction and decrease platelet count during CPB. No large randomized, double-blind, clinical trials have compared albumin solution to crystalloid solution in cardiac surgery.

Methods/design

In this single-center, double-blind, randomized controlled trial comprising 1386 adult cardiac surgery patients, 4% albumin solution will be compared to Ringer’s acetate solution in CPB priming and volume replacement up to 3200 mL during surgery and the first 24 h of intensive care unit stay. The primary efficacy outcome is the number of patients with at least one major adverse event (MAE) during 90 postoperative days (all-cause death, acute myocardial injury, acute heart failure or low output syndrome, resternotomy, stroke, major arrhythmia, major bleeding, infection compromising post-procedural rehabilitation, acute kidney injury). Secondary outcomes are total number of MAEs, incidence of major adverse cardiac events (MACE; cardiac death, acute myocardial injury, acute heart failure, arrhythmia), amount of each type of blood product transfused (red blood cells, fresh frozen plasma, platelets), total fluid balance at the end of the intervention period, total measured blood loss, development of acute kidney injury, days alive without mechanical ventilation in 90 days, days alive outside intensive care unit at 90 days, days alive at home at 90 days, and 90-day mortality.

Discussion

The findings of this study will provide new evidence regarding efficacy and safety of albumin solution in adult patients undergoing cardiac surgery with CPB.

Trial registration

EudraCT (clinicaltrialsregister.eu) 2015–002556-27 Registered 11 Nov 2016 and ClinicalTrials.gov NCT02560519. Registered 25 Sept 2015.

Details

Title
Effect and safety of 4% albumin in the treatment of cardiac surgery patients: study protocol for the randomized, double-blind, clinical ALBICS (ALBumin In Cardiac Surgery) trial
Author
Vlasov, Hanna 1   VIAFID ORCID Logo  ; Juvonen, Tatu 2 ; Hiippala, Seppo 1 ; Suojaranta, Raili 2 ; Peltonen, Markku 3 ; Schramko, Alexey 1 ; Arvonen, Kaapo 1 ; Salminen, Ulla-Stina 2 ; Kleine Budde, Ilona 4 ; Eränen, Tiina 5 ; Mazanikov, Maxim 1 ; Meinberg, Mihkel 1 ; Vähäsilta, Tommi 2 ; Wilkman, Erika 1 ; Pettilä, Ville 1 ; Pesonen, Eero 1 

 University of Helsinki and Helsinki University Hospital, Department of Anesthesiology and Intensive Care and Pain Medicine, Helsinki, Finland (GRID:grid.7737.4) (ISNI:0000 0004 0410 2071) 
 University of Helsinki and Helsinki University Hospital, Department of Cardiac Surgery, Heart and Lung Center, Helsinki, Finland (GRID:grid.7737.4) (ISNI:0000 0004 0410 2071) 
 National Institute for Health and Welfare, Helsinki, Finland (GRID:grid.14758.3f) (ISNI:0000 0001 1013 0499) 
 Sanquin Plasma Products B.V., Department of Clinical Operations, Amsterdam, The Netherlands (GRID:grid.417732.4) (ISNI:0000 0001 2234 6887) 
 University of Helsinki and Helsinki University Hospital, HUS Pharmacy, Helsinki, Finland (GRID:grid.7737.4) (ISNI:0000 0004 0410 2071) 
Pages
235
Publication year
2020
Publication date
Dec 2020
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2730332077
Copyright
© The Author(s). 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.