Using Argon for Ventilation After Cardiac Arrest

CardioPulmonary Resuscitation With Argon (CPAr) Trial

This study is testing if using argon gas mixed with oxygen can help protect the brain and heart in people who have just been resuscitated after a cardiac arrest.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mario Negri Institute for Pharmacological Research (Academic / other)
• Locations: 9 sites (Genova, GE and 8 other locations)
• Trial ID: NCT05482945 on ClinicalTrials.gov

What this trial studies

This trial investigates the use of argon gas as a ventilation mixture for patients who have been resuscitated from out-of-hospital cardiac arrest. It is a multicenter, randomized, controlled, single-blinded study focusing on safety assessments in a critical patient population. Eligible patients will receive argon in combination with oxygen within four hours of regaining spontaneous circulation, and outcomes will be monitored for six months. The study aims to determine if argon can reduce neurological and myocardial damage following cardiac arrest.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a witnessed non-traumatic out-of-hospital cardiac arrest with a shockable rhythm.

Not a fit: Patients who suffered a non-witnessed cardiac arrest or have a non-shockable rhythm will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients resuscitated from cardiac arrest.

How similar studies have performed: Previous studies have shown promising results with argon in animal models, but this is one of the first clinical trials to test its efficacy in humans.

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

Where this trial is running

Genova, GE and 8 other locations

• Ospedale Policlinico San Martino di Genova — Genova, Ge, Italy (Recruiting)
• Ospedale San Gerado — Monza, Mb, Italy (Recruiting)
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Milan, Italy (Recruiting)
• Azienda Ospedaliero - Universitaria di Parma — Parma, Parma, Italy (Not_yet_recruiting)
• Ospedale Civile Santa Maria degli Angeli di Pordenone — Pordenone, Pordenone, Italy (Recruiting)
• Arcispedale Santa Maria Nuova di Reggio Emilia — Reggio Emilia, Reggio Emilia, Italy (Not_yet_recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
• Ospedale Santa Chiara di Trento — Trento, Trento, Italy (Recruiting)
• Azienda Sanitaria Universitaria Giuliano Isontina (Asugi) di Trieste — Trieste, Ts, Italy (Recruiting)

Study contacts

• Principal investigator: Giuseppe Ristagno, MD, PhD — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Study coordinator: Giulia Merigo, MSc

Conditions Cardiac Arrest, Out-Of-Hospital; Cardiac Arrest With Successful Resuscitation; Cardiac arrest; Cardiopulmonary resuscitation; Argon.