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This study aimed at evaluating the efficacy and safety of high-dose (> 0.2 L/kg of treated plasma per day) coupled plasma filtration-adsorption (CPFA) in treating patients with septic shock. Multicentre, randomised, adaptive trial, performed in 12 Italian intensive care units (ICUs). Patients aged 14 or more, admitted to the ICU with septic shock, or had developed it during the stay were eligible. The final outcome was mortality at discharge from the last hospital at which the patient received care. Between May 2015, and October 2017, 115 patients were randomised. The first interim analysis revealed a number of early deaths, prompting an unplanned analysis. Last hospital mortality was non-significantly higher in the CPFA (55.6%) than in the control group (46.2%, p = 0.35). The 90-day survival curves diverged in favour of the controls early after randomisation and remained separated afterwards (p = 0.100). An unplanned analysis showed higher mortality in CPFA compared to controls among patients without severe renal failure (p = 0.025); a dose–response relationship was observed between treated plasma volume and mortality (p = 0.010). The COMPACT-2 trial was stopped due to the possible harmful effect of CPFA in patients with septic shock. The harmful effect, if present, was particularly marked in the early phase of septic shock. Patients not requiring renal replacement therapy seemed most exposed to the possible harm, with evidence of a dose–response effect. Until the mechanisms behind these results are fully understood, the use of CPFA for the treatment of patients with septic shock is not recommended.

To evaluate the performance of a new helmet (NH) recently introduced into clinical use relative to that of the standard helmet (SH) in terms of delivering non-invasive continuous positive airway pressure (nCPAP) and pressure support ventilation (nPSV).This was a bench study using a mannequin connected to an active lung simulator. The SH was fastened to the mannequin by armpit braces, which are not needed to secure the NH.The inspiratory and expiratory variations in nCPAP delivered with two different simulated efforts (Pmus), were determined relative to the preset CPAP level. nPSV was applied at two simulated respiratory rates (RR) and two cycling-off flow thresholds. We measured inspiratory trigger delay (Delay trinsp), expiratory trigger delay (Delay trexp), time of synchrony (Time sync), trigger pressure drop (ΔP trigger), airway pressure-time product during the triggering phase (PTPt), the initial 200 ms from the onset of the ventilator pressurization (PTP 200), and the initial 300 and 500 ms from the onset of the simulated effort; this two latter parameters were expressed as the percentage of the area of ideal pressurization (PTP 300-index and PTP 500-index, respectively).In nCPAP, at both Pmus, the differences between the two interfaces at both Pmus were small and clinically irrelevant. In nPSV, regardless of the setting, NH resulted in significantly smaller trigger delays, ΔP trigger, and PTPt. Time sync, PTP 200, PTP 300-index, and PTP 500-index were also significantly higher with the NH compared to the SH, irrespective of the setting.Compared to the SH, the NH is equally effective in delivering nCPAP and more effective in delivering nPSV, and it is used to avoid the need for armpit braces.

Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient-ventilator interaction and reduce asynchronies in intubated patients, as opposed to pressure support ventilation (PSV). This is a short-term head-to-head physiologic comparison between PSV and NAVA in delivering noninvasive ventilation through a helmet (h-NIV), in patients with postextubation hypoxemic acute respiratory failure.Ten patients underwent three 20-min trials of h-NIV in PSV, NAVA, and PSV again. Arterial blood gases (ABGs) were assessed at the end of each trial. Diaphragm electrical activity (EAdi) and airway pressure (P (aw)) were recorded to derive neural and mechanical respiratory rate and timing, inspiratory (delay(TR-insp)) and expiratory trigger delays (delay(TR-exp)), time of synchrony between diaphragm contraction and ventilator assistance (time(synch)), and the asynchrony index (AI).ABGs, peak EAdi, peak P (aw), respiratory rate, either neural or mechanical, neural timing, and delay(TR-exp) were not different between trials. Compared with PSV, with NAVA the mechanical expiratory time was significantly shorter, while the inspiratory time and duty cycle were greater. Time(synch) was 0.79 ± 0.35 s in NAVA versus 0.60 ± 0.30 s and 0.55 ± 0.29 s during the PSV trials (p 0.01 for both). AI exceeded 10% during both PSV trials, while not in NAVA (p 0.001).Compared with PSV, NAVA improves patient-ventilator interaction and synchrony, with no difference in gas exchange, respiratory rate, and neural drive and timing.

In sepsis, dysregulation of the immune response leads to rapid multiorgan failure and death. Accurate and timely diagnosis is lifesaving and should discriminate sepsis from the systemic inflammatory response syndrome (SIRS) caused by non-infectious agents. Osteopontin acts as an extracellular matrix component or a soluble cytokine in inflamed tissues. Its exact role in immune response and sepsis remains to be elucidated. Therefore, we investigated the role of osteopontin in SIRS and sepsis.Prospective, observational study.Intensive care unit of a university hospital.Fifty-six patients with SIRS or sepsis and 56 healthy subjects were enrolled.We analyzed the serum levels of osteopontin and TH1-TH2 cytokines and investigated the role of osteopontin on interleukin 6 secretion by monocytes.Serum osteopontin levels were strikingly higher in patients than in controls and in sepsis than in SIRS, and decreased during the resolution of both the disorders. Receiver operating characteristic curves showed that osteopontin levels have discriminative power between SIRS and sepsis with an area under the curve of 0.796. Osteopontin levels directly correlated with those of interleukin 6 and in vitro, recombinant osteopontin increased interleukin 6 secretion by monocytes in both the absence and presence of high doses of lipopolysaccharide.These data suggest that osteopontin might be a mediator involved in the pathogenesis of SIRS and sepsis, possibly by supporting interleukin 6 secretion.45. SIRS/Sepsis: clinical studies.

The objective was to examine the effect of repeated applications of coupled plasmafiltration-adsorption on the hemodynamic response in septic shock patients hospitalized in intensive care units (ICUs).Prospective, intention-to-treat.General ICU of a tertiary care, non-teaching, 400-bed, city hospital.Twelve consecutive mechanically ventilated septic shock patients, with or without concomitant acute renal failure (ARF).A median of 10 consecutive sessions (prescribed treatment time: 10 h/session; delivered duration: 8.43+/-1.37 h/min) of coupled plasmafiltration-adsorption for each patient.Mean arterial pressure (77.2+/-12.5 [CI 95%; 74.5-79.8] vs. 83.3+/-14.1 [CI 95%; 80.3-86.3] mm Hg; [ p0.001]), cardiac index (4.03+/-0.89 [CI 95%; 3.83-4.22] vs. 3.46+/-0.82 [CI 95%; 3.28-3.64] L/m(2)/min; [ p0.001]), systemic vascular resistance index (1,388+/-496 [CI 95%; 1,278-1,497] vs. 1,753+/-516 [CI 95%; 1,639-1,867] dynes x s/cm(5); [ p0.001]), PO2/FIO2 ratio (204+/-87 [CI 95%; 185-223] vs. 238+/-82 [CI 95%; 220-256]; [ p0.001]), significantly improved during 100 global treatments (pre- vs. post-treatment values). Intra-thoracic blood volume and extra-vascular lung water did not change across treatments. Vasopressor requirement was reduced: norepinephrine decrease from an infusion rate of 0.13+/-0.07 (CI 95%; 0.06-0.16) to 0 gamma/kg/min after a mean of 5.3+/-2.7 sessions. C reactive protein (CRP) significantly decreased (from 29.3+/-7.3 vs. 7.9+/-4.8; p0.0001) during treatment. Survival was 90% at day 28 and 70% at day 90.Coupled plasmafiltration-adsorption was a feasible and safe extracorporeal treatment and exerted a remarkable improvement in the hemodynamics, the pulmonary function, and the outcome in septic shock patients with or without concomitant ARF.