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

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.

Preoperative Pericardial Effusion is Associated with Low Cardiac Output Syndrome After Pericardiectomy for Constrictive Pericarditis

“…Due to the long-term compression of the thickened pericardium and myocardial ischemia, the heart denaturates and atrophies, and the heart has poor adaptability to the changes of hemodynamics [Fang 2020;Vlasov 2020;Acharya 2018]. After the heart is released, a large amount of blood flows back and the preload of the heart increases, which leads to the occurrence of heart failure or malignant arrhythmia, and even leads to cardiac arrest.…”

“…Fresh frozen plasma and albumin were properly imported. Regular antituberculosis treatment was given to patients with tuberculosis [Fang 2020;Vlasov 2020]. The patients with abnormal liver function should be treated with liver protective drugs and vitamin K1 should be used before operation.…”

“…In addition, monitoring CVP has guiding significance for postoperative treatment. After pericardiectomy, the heart is in a high-volume load state in a short period of time, and there is no concern of low blood volume [Vlasov 2020;Fang 2020]. At this time, large amount of diuresis becomes a feasible and necessary measure, which also is one of the key points for further improvement of cardiac function after operation.…”

Acute Kidney Injury: Lessons from Pericardiectomy

“…The following factors have been found to facilitate the development of AKI after cardiac surgery: age, female sex, obesity, low cardiac output, blood transfusion, valve replacement surgery, heart failure, myocardial infarction in the last 30 days, chronic obstructive pulmonary disease, peripheral artery disease, prolonged CPB, the use of inotropic or vasoconstrictor drugs, the use of an intra-aortic balloon pump, diabetes mellitus, systemic arterial hypertension, and chronic kidney disease [Dedemoğlu 2020;Husain-Syed 2020;Vlasov 2020;Hames 2019].…”

Air, inflammation and biocompatibility of the extracorporeal circuits

“…The coating can be divided into two categories and each of these coatings do have advantages and disadvantages. First, “the most common biopassive coatings” attenuating the protein adsorption and it is considered more “platelet friendly.” 2,3 Alternatively, we have the “active” coating: treatment of the internal surfaces in contact with the blood with neutral proteins and heparin that also attenuate the complement activation. The latter are different according to the production company, but the aim is always to maintain high levels of systemic and local anticoagulation, inactivating the “contact” coagulation between the blood and the surfaces.…”