Endpoints
thrombosis, AKI, bleeding, catheter-related complications, thrombopenia, infections, coagulation abnormalities, hematoma, acute kidney injury
THROMBOSIS, BLEEDING, KIDNEY DISEASE, THROMBOPENIA, EVENT, INFECTIONS, COMPLICATIONS, ANAPHYLACTOID REACTIONS, BLOOD, HEMATOMA, BRONCHOSPASM
Since this was a pilot study, we assessed the procedure’s feasibility, safety and efficacy.Feasibility was assessed by the ratio of included/screened patients, the time to therapy initiation and the percentage of patients who actually received > 12 h of HA in the intervention group.Safety endpoints included anaphylactoid reactions, bronchospasm, bleeding complications, need for red blood cells transfusion, coagulation abnormalities (defined as a systemic aPTT ≥ 1.5 times baseline value), catheter-related complications (thrombosis, hematoma at insertion site, infections) and new-onset thrombopenia (thrombocytes < 150 G/l) within one and 2 days after randomization. Any other untoward event was recorded and reported.Efficacy was assessed by the trend in cytokines’ plasma levels within 72 h of randomization and their absolute and relative reduction at 48 h compared to the baseline value (randomization). A large panel of cytokines was assessed including pro-inflammatory (IL-1β, IL-2, IL-6, IL-8, IL-5, interferon (IFN)-γ, GM-CSF, TNF-α) and anti-inflammatory (IL-4, IL-10) mediators. The relative reduction was calculated using the following formula:Blood samples for cytokines analysis were drawn from the arterial line or the central venous catheter at six time points (randomization, 6, 12, 24, 48 and 72 h post-randomization) into ethylenediaminetetraacetic acid tubes. They were centrifuged at 1500 RPM at 4 °C for 10 min. Three aliquots of 100 μl plasma were prepared and stored at − 80 °C. Cytokines analyses were performed using a Human Cytokine Magnetic 10-Plex Panel on the LuminexSecondary endpoints included serum levels of C-reactive protein at day 2, acute kidney injury (AKI) during ICU stay (as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines 2012 [