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The trial was made possible thanks to an unrestricted grant from Alung Technologies Inc, Maquet (Getinge Group), and Novalung (Xenios now part of Fresenius Medical). They supported the costs of the data monitoring and site visits, the insurance fees, the supply of the equipment and materials, the shipments and the fees per patient. The grants from the companies amounted to (sic)171,000 and were made available to the European Society of Intensive Care Medicine that supported the costs of the development and running of the eCRF platform, the IT infrastructure, and the administrative costs related to legal matters and contracting (insurance contracts, data use agreements, and hospital contracts).

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Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: the SUPERNOVA study

Publicat a:Intensive Care Medicine. 45 (5): 592-600 - 2019-01-01 45(5), DOI: 10.1007/s00134-019-05567-4

Autors: Combes, Alain; Fanelli, Vito; Pham, Tai; Ranieri, V. Marco; Goligher, Ewan C.; Brodie, Daniel; Pesenti, Antonio; Beale, Richard; Brochard, Laurent; Chiche, Jean-Daniel; Fan, Eddy; de Backer, Daniel; Francois, Guy; Ferguson, Niall; Laffey, John; Mercat, Alain; McAuley, Daniel F.; Mueller, Thomas; Quintel, Michael; Vincent, Jean-Louis; Taccone, Fabio Silvio; Peperstraete, Harlinde; Morimont, Philippe; Schmidt, Matthieu; Levy, Bruno; Diehl, Jean-Luc; Guervilly, Christophe; Capelier, Gilles; Vieillard-Baron, Antoine; Messika, Jonathan; Karagiannidis, Christian; Moerer, Onnen; Urbino, Rosario; Antonelli, Massimo; Mojoli, Francesco; Alessandri, Francesco; Grasselli, Giacomo; Donker, Dirk; Ferrer, Ricard; Mancebo, Jordi; Slutsky, Arthur S.;European Soc Intensive Care Med Tr; Strategy Ultra-Protective Lung Ven

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PurposeWe assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO2R) to facilitate ultra-protective ventilation (V-T 4mL/kg and P(PLAT)25cmH(2)O) in patients with moderate acute respiratory distress syndrome (ARDS).MethodsProspective multicenter international phase 2 study. Primary endpoint was the proportion of patients achieving ultra-protective ventilation with PaCO2 not increasing more than 20% from baseline, and arterial pH>7.30. Severe adverse events (SAE) and ECCO2R-related adverse events (ECCO2R-AE) were reported to an independent data and safety monitoring board. We used lower CO2 extraction and higher CO2 extraction devices (membrane lung cross-sectional area 0.59 vs. 1.30m(2); flow 300-500mL/min vs. 800-1000mL/min, respectively).ResultsNinety-five patients were enrolled. The proportion of patients who achieved ultra-protective settings by 8h and 24h was 78% (74 out of 95 patients; 95% confidence interval 68-89%) and 82% (78 out of 95 patients; 95% confidence interval 76-88%), respectively. ECCO2R was maintained for 5 [3-8]days. Six SAEs were reported; two of them were attributed to ECCO2R (brain hemorrhage and pneumothorax). ECCO2R-AEs were reported in 39% of the patients. A total of 69 patients (73%) were alive at day 28. Fifty-nine patients (62%) were alive at hospital discharge.ConclusionsUse of ECCO2R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms.Clinicaltrials.govNCT02282657

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