NCT05482945 CardioPulmonary Resuscitation With Argon (CPAr) Trial
| NCT ID | NCT05482945 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mario Negri Institute for Pharmacological Research |
| Condition | Cardiac Arrest, Out-Of-Hospital |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-05-30 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2022-05-30 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Giuseppe Ristagno, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Frequently Asked Questions
Who can join the NCT05482945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest, Out-Of-Hospital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05482945 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05482945 currently recruiting?
Yes, NCT05482945 is actively recruiting participants. Contact the research team at giulia.merigo@unimi.it for enrollment information.
Where is the NCT05482945 trial being conducted?
This trial is being conducted at Genova, Italy, Monza, Italy, Milan, Italy, Parma, Italy and 5 additional locations.
Who is sponsoring the NCT05482945 clinical trial?
NCT05482945 is sponsored by Mario Negri Institute for Pharmacological Research. The principal investigator is Giuseppe Ristagno, MD, PhD at Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 120 participants.