Outcome parameters

EN Endre Nemeth
AS Adam Soltesz
EK Eniko Kovacs
ZS Zsofia Szakal‐Toth
ET Eszter Tamaska
HK Hajna Katona
KR Kristof Racz
GC Gergely Csikos
VB Viktor Berzsenyi
SF Szabolcs Fabry
ZU Zsuzsanna Ulakcsai
CT Csilla Tamas
BN Beata Nagy
MV Marina Varga
BM Bela Merkely
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The primary outcome of this trial was early post‐operative haemodynamic instability quantified by the vasoactive‐inotropic score (VIS), frequency of VS and length of vasopressor need. VIS was calculated according to the formula: VIS = dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100× adrenaline dose (μg/kg/min) + 10× phosphodiesterase inhibitor dose (μg/kg/min) + 100× noradrenaline dose (μg/kg/min) + 10 000× vasopressin dose (U/kg/min) 18 based on the mean doses in the post‐operative first 24 h for each agent. VIS was considered as ‘high’ if values ≥30 points, representing a higher risk for unfavourable outcomes. 19 Quantitative criteria of VS were mean noradrenaline requirements ≥0.3 μg/kg/min and need for argipressin supplementation at any dose to achieve a MAP >60 mmHg assessed over the first 24 h.

Secondary outcome parameters were defined as the inflammatory response characterized by a 72‐h change in procalcitonin (PCT) and C‐reactive protein (CRP) levels; duration of MV; surgery associated bleeding and reoperation for bleeding; frequency and severity of acute kidney injury (AKI) classified by applying the KDIGO creatinine‐based definition criteria for the first 5 post‐operative days 20 ; 24‐h per cent change in bilirubin level using the equation: PCB = ([post‐CPB 24‐h bilirubin level (mg/dL)] − [pre‐operative bilirubin level (mg/dL)]/[pre‐operative bilirubin level (mg/dL)]) × 100, frequency of early sepsis screened for in the first 5 post‐operative days; length of ICU and hospital stay; intraoperative change in MPA plasma concentration; early allograft rejection; 30‐day mortality rate and 1‐year survival. Biomarkers of inflammatory response and creatinine clearance as well as the total bilirubin serum concentration were quantified from venous blood samples collected at designated time points using standard validated laboratory measurements.

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