The international, prospective COSMOS (CytOSorb® TreatMent Of Critically Ill PatientS) Registry: results from the first 300 patients.
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Ошибки и ограничения
История · было → стало
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Ferrer Ricard, Thielmann Matthias, Unglaube Moritz, Kirschning Thomas, Baumann Andreas, Kreutz Julian, Kribben Andreas, Tyczynski Bartosz, Guenther Ulf, Henzler Dietrich, Scharf Christina, Germano Nuno, Bellgardt Martin, El-Essawi Aschraf, Hohlstein Philipp, Guenther Thomas, Schulze P Christian, Aucella Filippo, Fernandez Mario Marquez, Koestenberger Markus, Bottari Gabriella, Hidalgo Jorge, Teboul Jean-Louis, Tomescu Dana, Klaus Teresa, Fan Weihong, Scheier Joerg, Deliargyris Efthymios N, Taccone Fabio Silvio
Аннотация
METHODS: The international prospective COSMOS Registry (NCT05146336, 23 Nov 2021) tracks CytoSorb® (CS) utilization patterns and outcomes in critical care settings. Clinical assessment was performed before, during, and after CS treatment, with a 90-day follow-up. Device-related adverse effects were reported by investigators as the safety evaluation. Data were analyzed according to a pre-specified statistical plan using descriptive statistics and paired tests to compare pre- and post-treatment values, with subgroup and safety analyses performed.
RESULTS: A total of 300 adult patients (30.3% female, mean age 59 ± 15 years) from 22 sites were included in this analysis. The most common indications for CS therapy (multiple indications possible per patient) were septic shock (48.3%), rhabdomyolysis (12.8%), cardiogenic shock (11.5%), liver failure (11.5%), and acute respiratory distress syndrome (ARDS; 5.0%). On average, each patient received 3.3 ± 3.3 adsorbers, with 27.9% of patients receiving 4 or more adsorbers. CS was integrated in conjunction with kidney replacement therapy (75.6%), standalone hemoperfusion (7.1%), intermittent hemodialysis (IHD; 10.6%), extracorporeal membrane oxygenation (ECMO; 3.9%), and sustained low-efficiency daily dialysis (SLEDD; 4.9%). At baseline, median (interquartile range, IQR) APACHE II and SOFA scores were 24 [18, 30] and 12 [9, 15], respectively. Fluid balance improved from +1675 [141, 3348] mL pre-CS to +115 [-1100, 1495] mL post-CS, and norepinephrine requirements decreased from 0.21 [0.09, 0.40] µg/kg/min to 0.08 [0.02, 0.22] µg/kg/min (p < 0.0001 for both). Ratio of partial pressure of oxygen in arterial blood to the fraction of inspiratory oxygen concentration (P/F ratio) improved from 120 [72, 208] to 176 [115, 255] (p < 0.0001). Platelet counts decreased from 123 [76, 185] to 72 [42, 118] × 109/L (p < 0.0001), while albumin levels remained stable from 2.6 [2.3, 3.1] to 2.5 [2.3, 3.0] g/dL (p = 0.112). ICU mortality was 33.1%, which was lower than mortality estimates historically associated with comparable APACHE II and SOFA scores. No serious adverse effects related to the device or device deficiencies were reported.
CONCLUSIONS: Real-world CytoSorb® use as part of standard care in critically ill patients was associated with improvements in several clinical and laboratory parameters; however, these findings should be interpreted cautiously given the observational design and absence of a control group. Observed mortality was lower than mortality estimates historically associated with established severity scores.