RecruitingPhase 2NCT05482945

CardioPulmonary Resuscitation With Argon (CPAr) Trial


Sponsor

Mario Negri Institute for Pharmacological Research

Enrollment

120 participants

Start Date

May 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Preclinical studies suggest that argon (Ar) might diminish the neurological and myocardial damage after any hypoxic-ischemic insult. Indeed, Ar has been tested in different models of ischemic insult, at concentrations ranging from 20% up to 80%. Overall, Ar emerged as a protective agent on cells, tissues and organs, showing less cell death, reduced infarct size and faster functional recovery. More specifically, encouraging data has been reported in animal studies on cardiac arrest (CA) in which a better and faster neurological recovery was achieved when Ar was used in the post-resuscitation ventilation. More importantly, these benefits have been replicated in different studies, enrolling both small and large animals. Finally, ventilation with Ar in O2 has been demonstrated to be safe both in animals and humans. Based on this evidence, a clinical translation is advocated. Thus, the CardioPulmonary resuscitation with Argon - CPAr trial has been conceived. The trial initially started as phase I-II trial to specifically address the question about the safety of the post resuscitation Ar-treatment. The available data on the first 30 randomized patients, evaluated by the Data Safety Monitoring Board (DSMB), were considered absolutely reassuring with regard to the safety of the experimental treatment. In this perspective, the DSMB supported the continuation of the study as a phase II trial, maintaining the study protocol in all its aspects. Thus, the aim of the CPAr trial is now to evaluate efficacy in reducing post-CA neurological injury of Ar/O2 ventilation in patients resuscitated from CA.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • ICU admission after resuscitation from witnessed non-traumatic out-of-hospital cardiac arrest (OHCA) of presumably cardiac etiology with a presenting shockable rhythm;
  • age ≥ 18 years;
  • unconsciousness after return of spontaneous circulation (ROSC);
  • duration of CPR ≤ 40 mins;
  • initiation of study intervention ≤ 4 hrs from ROSC;
  • stable SaO2 ≥ 94% with a FiO2 of 30%.

Exclusion Criteria9

  • Non-witnessed CA;
  • CA of traumatic origin or from a non-presumably cardiac cause;
  • CA with a non-shockable presenting rhythm (pulseless electrical activity and asystole);
  • female of childbearing potential defined as younger of 50 years;
  • pregnancy;
  • known terminal illness;
  • pre-CA cerebral performance category (CPC) ≥ 3;
  • initiation of the study intervention \> 4 hrs from ROSC;
  • participation to another clinical trial

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNoble gas Argon

Ventilation with Ar 70%/O2 30% in comatose patients resuscitated from OHCA with the use of an experimental mechanical ventilator.


Locations(9)

Ospedale Policlinico San Martino di Genova

Genova, GE, Italy

Ospedale San Gerado

Monza, MB, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milan, Italy

Azienda Ospedaliero - Universitaria di Parma

Parma, Parma, Italy

Ospedale Civile Santa Maria degli Angeli di Pordenone

Pordenone, Pordenone, Italy

Arcispedale Santa Maria Nuova di Reggio Emilia

Reggio Emilia, Reggio Emilia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

Ospedale Santa Chiara di Trento

Trento, Trento, Italy

Azienda Sanitaria Universitaria Giuliano Isontina (Asugi) di Trieste

Trieste, TS, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05482945


Related Trials