| Contributors: |
Ristagno, G.; Staszewsky, L.; Merigo, G.; Magliocca, A.; Cucino, A.; Meessen, J.; Fumagalli, F.; Pozzi, Matteo; Galazzi, A.; Sandroni, C.; Meneguzzi, M.; Marangone, A.; Robba, C.; Roman-Pognuz, E.; Salati, G.; Picetti, E.; Novelli, D.; Bellani, G.; Panigada, M.; Wik, L.; Garattini, S.; Foti, Tullio Febo Giuseppe; Antonelli, Massimo; Zanier, E.; Grasselli, Giacomo; Latini, Roberto; Maggioni, A. P.; Semeraro, F.; Tognoni, G.; Finzi, A.; Fumagalli, R.; Pesenti, A.; Nicolis, E.; Colombo, Martina; Fracasso, C.; Gobbi, M.; Giussani, G.; Hellmann, N.; Monfrini, S.; Balosso, S. M.; Carlucci, L.; Vasami, A.; Castaldi, S.; Preti, A.; Ferrarini, L.; Libretti, G. A.; Roselli, P.; Abbruzzese, C.; Bottino, N.; Rosati, Alessandra; Silvestri, I.; Mariani, I.; Normanno, M.; Rezoagli, E.; De Santis, P.; Todesco, N.; Pellis, T.; Sagnelli, V.; Patroniti, N.; Battaglini, D.; Gualdi, F.; Manzoni, P.; Migliari, M.; Grossi, S.; Manstretta, S.; Balzani, E.; Macchini, E.; Colussi, G.; Gamberini, L.; Tavazzi, G.; Savastano, S. |
| Description: |
Aims: The CardioPulmonary resuscitation with Argon (CPAr) trial evaluates the clinical neuroprotective efficacy and safety of post-resuscitation ventilation with a 70/30 argon/oxygen (Ar/O2) gas mixture compared to standard care ventilation with 30% O2 in unconscious adults resuscitated from out-of-hospital cardiac arrest (OHCA). Methods: CPAr is an allocation-concealed, single-blinded, multi-centre, phase II, pre-marketing, randomised controlled trial (RCT). The study aims to recruit 120 patients across tertiary intensive care units (ICUs) in Italy. Eligible participants are unconscious adult OHCA survivors with a shockable presenting rhythm. Upon ICU admission, patients are individually randomised in a 1:1 ratio to receive either 4-h ventilation with 70/30 Ar/O2 via an experimental ventilator, or standard ICU ventilation with 30% O2. All patients receive guideline-based post-resuscitation care. Inclusion is conducted under a deferred consent model, with consent obtained from patients or legal representatives once clinically appropriate. The primary clinical efficacy outcome is serum neuron-specific enolase (NSE) concentration at 48 h, as a surrogate marker of neurological injury. Secondary outcomes include markers of myocardial and multiorgan injury, neuroimaging signs of brain injury, survival, and neurological recovery (Cerebral Performance Category, CPC) up to 6 months. Safety outcomes include the incidence, timing, and duration of O2 desaturation requiring discontinuation of Ar, and haemodynamic adverse events. Patients are followed up to 6 months, with outcome assessment at ICU/hospital discharge, 1- and 6-months post-CA. A centralized plasma and serum biobank will support future mechanistic analyses. Conclusion: CPAr trial is the first RCT to assess the efficacy and safety of Ar ventilation in humans following OHCA and may inform future neuroprotective strategies in post-resuscitation care. Trial registration: EudraCT-No.: 2018-003047-32; CTIS code: 2024-516864-27-00; ClinicalTrials.gov identifier: ... |