Endothelial Dysfunction, Inflammation and Oxidative Stress (EDIOS) in patients undergoing cardiac surgery with pulsatile or non-pulsatile cardiopulmonary bypass: a multi-centric randomised controlled trial

Slovenian Research and Innovation Agency0 sites144 target enrollmentMay 21, 2024

Overview

No summary available.

Registry

who.int

Start Date

May 21, 2024

End Date

January 1, 2027

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Slovenian Research and Innovation Agency

•1\. Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
•2\. Expected aortic cross\-clamp (ACC) time of \>45 minutes
•3\. Full or partial median sternotomy with central cannulation (mini\-CPB should not be used)
•4\. surgery starting in the morning:
•4\.1\. Cardiac valve surgery
•4\.2\. Isolated coronary artery bypass grafting (CABG)
•4\.3\. Combination of valvular and CABG surgery
•4\.4\. Any of the above combined with ascending aorta surgery
•(NO concomitant radio\-frequency ablations, NO concomitant carotid artery surgery)

•1\. Refusal to participate in the study
•2\. Pregnant women
•3\. Patients with previous cardiac surgery (i.e., redo surgery)
•4\. Patients with left ventricular ejection fraction \<30%
•5\. Patients on chemo/immunosuppressive therapy (including inhaled corticosteroids, antileukocyte drugs or TNF\-a blockers)
•6\. Patients with body mass index, \>35 kg·m\-2 or \<18 kg·m\-2
•7\. Patients with a body surface area (BSA \- duBois formula) \>2\.20 m2 (as it would be impossible to achieve pulsatile pump flow equivalent to a cardiac index of 2\.0\-2\.4, without exceeding maximum safe line pressure in the extracorporeal circuit)
•8\. Patients with any autoimmune diseases, immunocompromised patients (e.g., with AIDS) or with leucopoenia (\<3\.5·109 cells·L\-1\)
•9\. Clinical and/or laboratory signs of infection
•10\. Patients with advanced chronic lung disease with pO2 on air: \<9\.8 kPa