Prevention of postoperative pulmonary complications after cardiac surgery with extracorporeal circulation Respiratory
Conditions
Interventions
Randomization will be conducted by assigning each consecutive respondent in a 1:1 manner to either the control (A) or intervention (B) groups. The order of this allocation will be determined through m
Sponsors
University of Belgrade
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old 2. Undergoing an elective cardiac surgery (CS) procedure with extracorporeal circulation (ECC), regardless of the type of planned operation
Exclusion criteria
Exclusion criteria: 1. Previous CS operation 2. Emergency patients 3. Clinically and/or radiographically active lung disease 4. The systolic pressure in the pulmonary artery >60 mm Hg 5. Allergy to ascorbic acid 6. Gout 7. Hemodialysis 8. Significant oxaluria 9. Uric nephrolithiasis 10. Glu-cose-6-phosphate dehydrogenase enzyme deficiency 11. Hemochromatosis 12. Sickle cell anemia 13. Sideropenic anemia 14. Thalassemia 15. Operations with an ECC time =6h 16. Death during hospitalization caused by non-pulmonary reasons 17. Withdrawal of previously given consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The severity of postoperative pulmonary complications (PPC) measured using the modified Kroenke’s scoring tool daily at baseline, and during the first 7 postoperative days 2. The incidence of PPC measured using the modified Kroenke’s scoring tool daily, at baseline and during the first 7 postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are grouped as follows: 1. Pulmonary Oxygenation and Ventilation: 1.1. Horowitz Index: PaO2/FiO2 – is calculated by using PaO2 values from the ABG analysis and FiO2 from the oxygen delivery device, 48 hours after the surgery 1.2. Alveolar–arterial Gradient: A-aDO2 – is directly recorded from the ABG analyzer, 48 hours after the surgery 1.3. Time Spent on Mechanical Ventilation – is calculated for each patient before the transfer from the ICU as the total number of hours spent on mechanical ventilation, from the time of intubation (or initiation of non-invasive ventilation) to the time of extubation (or discontinuation of non-invasive ventilation). 2. Inflammatory Markers: (Procalcitonin, C-reactive Protein, Leucocytes, Neutrophils, Lymphocytes, Sedimentation Rate, Fibrinogen, Albumin, D-dimer, and Ferritin) all measured from blood samples processed in the clinical hematological and biochemical laboratory following standard hospital laboratory protocols and recorded at baseline, 0, 24, 48, 72 and 96 hours after the surgery 3. Renal Function: (Glomerular Filtration Rate (GFR) < 60mL/min, Creatinine, Urea) all measured from blood samples processed in the clinical hematological and biochemical laboratory following standard hospital laboratory protocols and recorded at baseline, 0, 24, 48, 72 and 96 hours after the surgery 4. Non-pulmonary Postoperative Complications: (Postoperative nausea and vomiting -PONV, delirium, transfusion, acute renal failure, wound infection, cardio-pulmonary-resuscitation – CPR) all assessed as an episode (event) after being assessed and documented by the blinded attending practitioner and recorded using the medical documentation tool before the discharge from the hospital 5. Postoperative Organ Dysfunction: 1. SOFA Score - Sequential Organ Failure Assessment (SOFA) score calculated and recorded by a blinded assistant 48 hours after the surgery 2. ASA/SOFA Ratio - The American Society of Anesthesiologists ( | — |
Countries
Serbia
Contacts
Public ContactMilica;Mladen Karadžic Kocica;Kocica
;
Outcome results
None listed