About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Noble gas Argon
DrugVentilation with Ar 70%/O2 30% in comatose patients resuscitated from OHCA with the use of an experimental mechanical ventilator.
Treatment groups
Trial outcomes
Primary outcomes
Neuronal preservation
Efficacy of Argon treatment in reducing post-CA neurological injury, assessed as 48hr serum concentration of the Neuron Specific Enolase (NSE), an established biomarker of brain injury.
Secondary outcomes
Myocardial preservation
Ar effect on myocardial protection is assessed through measure of hs-cTnT release
Brain injury
Ar effect on brain injury is assessed through MRI (imaging) if patient remains comatose
Survival
Effect of argon on survival after cardiac arrest (days)
Neurological recovery
Neurological functional recovery is assessed with the CPC score
Sponsors and contacts
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