Table 1.
Preoperative period |
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Central venous catheter insertion followed by a chest X-ray in order to evaluate catheter position and exclude any insertion-related complications |
Blood sampling to measure participant’s baseline PCT levels |
Deep vein thrombosis prophylaxis (enoxaparine) |
Antimicrobial prophylaxis (ciprofloxacin and metronidazole) |
Oral carbohydrate loading (maltodextrin) |
Intraoperative period |
General anaesthesia combined with lumbar epidural analgesia |
Lung protective ventilation applying FiO2 of 50% in both groups |
Continuous invasive arterial blood pressure monitoring |
Continuous capnography and heart rate monitoring |
Respiratory mechanics parameters (static pulmonary compliance, airway resistance, dead space fraction) data recording every 15 min |
Core temperature and train-of-four relaxometry data recording every 15 min |
Regular ABG and CVBG sampling every 60 min |
Maintenance fluid: 3 ml kg−1 h−1 of balanced crystalloid solution until the end of surgery |
Rescue fluid: 200 ml of colloid solution bolus (hydroxyethyl starch) and crystalloid substitution in case of bleeding |
Transfusion: PRBC transfusion, whenever the attending anaesthetist rendered it necessary |
Vasopressor treatment: intravenous norepinephrine to maintain MAP above 65 mmHg |
PCT sampling: 2 and 6 h after surgical incision intraoperatively |
Postoperative period (POD1-3) |
Continuous epidural analgesia combined with intravenous analgesics |
Continuous intraabdominal pressure monitoring |
Intravenous and oral fluid supplementation and if required, further transfusion |
Oral clear fluids immediately after surgery |
Removal of nasogastric tube at the latest on POD1 in the morning |
Prokinetics and an oral liquid diet from POD1 |
Active mobilization with the help of a physiotherapist from POD1 |
Evaluation of patient’s ABG, CVBG, PaO2/FiO2 and dCO2 every 6 h from POD1 to POD3 |
Evaluation of PCT levels at 12, 24, 48 and 72 h after surgical incision |
Chest X-ray (evaluated by an independent trained radiologist who was not be involved in the study) on POD1, POD2 and POD3 |
Monitoring of patients' clinical progress and secondary endpoints by daily SOFA scores, laboratory and physical examinations |
Follow-up period (POD4-28) |
Evaluation of secondary endpoints, in-hospital stay, 28-days and in-hospital mortality |
PCT procalcitonin; FiO2 fractional inspired oxygen; ABG arterial blood gas sample; CVBG central venous blood gas sample; PRBC packed red blood cells; MAP mean arterial pressure; POD postoperative day; PaO2/FiO2 ratio of arterial oxygen partial pressure to fractional inspired oxygen; dCO2 central venous-to-arterial carbon dioxide difference; PPC postoperative pulmonary complications; SOFA sequential organ failure assessment