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

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Vlasov , H , Juvonen , T , Hiippala , S , Suojaranta , R , Peltonen , M , Schramko , A , Arvonen , K , Salminen , U-S , Kleine Budde , I , Eränen , T , Mazanikov , M , Meinberg , M , Vähäsilta , T , Wilkman , E , Pettilä , V & Pesonen , E 2020 , ' 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 ' , Trials , vol. 21 , no. 1 , 235 . https://doi.org/10.1186/s13063-020-4160-3

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; Juvonen, Tatu; Hiippala, Seppo; Suojaranta, Raili; Peltonen, Markku; Schramko, Alexey; Arvonen, Kaapo; Salminen, Ulla-Stina; Kleine Budde, Ilona; Eränen, Tiina; Mazanikov, Maxim; Meinberg, Mihkel; Vähäsilta, Tommi; Wilkman, Erika; Pettilä, Ville; Pesonen, Eero
Contributor: University of Helsinki, Anestesiologian yksikkö
University of Helsinki, Department of Surgery
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, Clinicum
University of Helsinki, HUS Heart and Lung Center
University of Helsinki, HUS Helsinki and Uusimaa Hospital District
University of Helsinki, Department of Diagnostics and Therapeutics
University of Helsinki, Clinicum
University of Helsinki, HUS Heart and Lung Center
University of Helsinki, Department of Diagnostics and Therapeutics
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
Date: 2020-02-28
Language: eng
Number of pages: 10
Belongs to series: Trials
ISSN: 1745-6215
URI: http://hdl.handle.net/10138/313662
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.
Subject: Albumin
Ringer's acetate
Cardiac surgery
Cardiopulmonary bypass
Fluid management
HYDROXYETHYL STARCH
CARDIOPULMONARY BYPASS
FLUID
RESUSCITATION
METAANALYSIS
MANAGEMENT
OUTCOMES
3126 Surgery, anesthesiology, intensive care, radiology
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