Trial Outcomes & Findings for Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction. (NCT NCT02836899)

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.

Acute kidney injury (AKI) is defined by KDIGO criteria as an abrupt (within 48h) reduction in kidney function correlated to an absolute increase in serum creatinine of 0.3 mg/dL or more (≥26.4 μmol/L) or a percentage increase in serum creatinine of 50% or more (1.5-fold from baseline) at any time during the first 7 days after surgery or, finally, a reduction in urine output with a documented oliguria of \< 0.5 ml/Kg/h for \>6h.

Difference in AKI severity between the two groups using following KDIGO stages.

To study the incidence of acute renal failure requiring RRT

Difference between groups of MAKE at 6 weeks after surgery. MAKE is a composite outcome of death, new dialysis and worsened renal function (defined as a 25% or greater decline in eGFR compared to the baseline).

Assessment of organ dysfunction through the evaluation of SOFA score

Difference between groups of prolonged cardiovascular support defined as need for vasopressors, inotropic agents, balloon pump, or ventricular-assist device for more than 48 hours after cardiac surgery.

Difference between groups of maximum daily VIS and duration of vasopressors and or inotropic agents support. VIS is calculated as Dopamine dose (mcg/kg/min) + Dobutamine dose (mcg/kg/min) + 100 x Epinephrine dose (mcg/kg/min) + 10 x Milrinone dose (mcg/kg/min) + 10,000 x Vasopressin dose (units/kg/min) + 100 x Norepinephrine dose (mcg/kg/min) + 10 x Phenilephrine dose (mcg/kg/min).

Difference of duration of mechanical ventilation

Difference between groups of ICU-LOS defined as number of days spent in an ICU bed.

Difference between groups of hospital LOS defined as number of days spent in a hospital bed.

Renal biomarkers to evaluate renal tubular injury.

Incidence and severity of AKI related to presence of CKD at baseline, duration of CPB, duration of aortic cross clamp, levels of free Hb, levels of NO consumption, pulmonary pressure at baseline, cardiovascular risks associated with endothelial dysfunction, scheduled procedure and EuroSCORE II.

Difference between groups of Incidence of Delirium will be assessed daily in the first 7 days after surgery by using the confusion assessment method for intensive care unit (CAM-ICU).

Analysis of the quality of life up to 1 year after surgery by the Activity of Daily Living evaluation (by Katz Index) and PROMIS global health.

Evaluation of the overall intrahospital mortality and at 28 6 weeks 90 days and 1 year after surgery

Blood methemoglobin levels will be measured to evaluate the oxidation of oxyhemoglobin in the two groups until 48h after surgery.

Difference between groups of incidence of non fatal stroke will be assessed by at 6 weeks after cardiac surgery.

Incidence of Perioperative and non-perioperative nonfatal myocardial infarction as defined by the third universal definition of MI released in 2012 by the ESC/ACCF/AHA/WHF.

Incidence of postoperative bleeding calculated as the sum of blood loss through thoracic drains from the moment of closure of the chest over a period of 24 hours.

Differences between the two groups of transfusions with plasma and stored or autologous red blood cells (RBCs) recovered using intraoperative cell salvage devices.

Post-operative infections (e.g., pneumonia, wound infection, endocarditis, central line infection, urinary tract infection, sepsis).

Cardiac arrhythmias and other non-cardiac post-operative complications (e.g., hepatobiliary disorders, pneumothorax, pleural effusion, vascular disorders).