Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05482945

CardioPulmonary Resuscitation With Argon (CPAr) Trial Evaluating Argon/Oxygen Ventilation After Out-of-Hospital Cardiac Arrest

Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-09-17

120

Participants Needed

9

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of argon gas mixed with oxygen as a treatment to reduce neurological and heart damage after cardiac arrest outside of the hospital. Preclinical studies in animals showed argon may protect cells and improve recovery following low oxygen events. The CardioPulmonary Resuscitation with Argon (CPAr) trial began as a phase I-II safety study and is now continuing as a phase II trial to evaluate argon's effect on brain injury after cardiac arrest. In this randomized, controlled, single-blind study, patients who have been resuscitated from out-of-hospital cardiac arrest will receive ventilation with either a mixture of 70% argon and 30% oxygen or standard ventilation with 30% oxygen for four hours. Both groups will be treated according to established European resuscitation and intensive care guidelines. The study treatment lasts four hours, followed by monitoring over a six-month period to assess safety and clinical outcomes. Participants will be closely monitored during and after treatment with assessments including neurological function, heart function, brain injury markers, survival rates up to six months, and multiorgan function. Safety will be evaluated by recording any adverse events within one month. The main outcome focuses on neuronal preservation measured 48 hours after treatment. This comprehensive follow-up aims to understand argon's potential impact on recovery after cardiac arrest over both the short and long term.

CONDITIONS

Brief Title

CardioPulmonary Resuscitation With Argon (CPAr) Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ICU admission after resuscitation from witnessed non-traumatic out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause with shockable rhythm
  • Age 18 years or older
  • Unconscious after return of spontaneous circulation (ROSC)
  • Cardiopulmonary resuscitation duration 40 minutes or less
  • Study intervention started within 4 hours of ROSC
  • Stable blood oxygen saturation (SaO2) of 94% or higher with 30% oxygen (FiO2)
Not Eligible

You will not qualify if you...

  • Cardiac arrest not witnessed
  • Cardiac arrest due to trauma or non-cardiac cause
  • Cardiac arrest with non-shockable rhythm (pulseless electrical activity or asystole)
  • Female under 50 years of age who can become pregnant
  • Pregnancy
  • Known terminal illness
  • Pre-cardiac arrest cerebral performance category of 3 or higher
  • Study intervention started more than 4 hours after ROSC
  • Participation in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 4 hours

Participants receive ventilation with either Argon/Oxygen mixture or standard oxygen ventilation for 4 hours after resuscitation from out-of-hospital cardiac arrest.

1 treatment period during ICU stay

Follow-up

Duration - Up to 6 months

Participants are monitored for clinical events, neurological recovery, and survival up to 6 months after treatment.

Assessments at ICU discharge, 1 month, and 6 months

Trial Site Locations

Total: 9 locations

1

Ospedale Policlinico San Martino di Genova

Genova, GE, Italy, 16132

Actively Recruiting

2

Ospedale San Gerado

Monza, MB, Italy, 20900

Actively Recruiting

3

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milan, Italy, 20122

Actively Recruiting

4

Azienda Ospedaliero - Universitaria di Parma

Parma, Parma, Italy, 43126

Not Yet Recruiting

5

Ospedale Civile Santa Maria degli Angeli di Pordenone

Pordenone, Pordenone, Italy, 33170

Actively Recruiting

6

Arcispedale Santa Maria Nuova di Reggio Emilia

Reggio Emilia, Reggio Emilia, Italy, 42123

Not Yet Recruiting

7

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy, 00168

Actively Recruiting

8

Ospedale Santa Chiara di Trento

Trento, Trento, Italy, 38122

Actively Recruiting

9

Azienda Sanitaria Universitaria Giuliano Isontina (Asugi) di Trieste

Trieste, TS, Italy, 34148

Actively Recruiting

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Research Team

G

Giulia Merigo, MSc

A

Antonella Vasamì

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

CardioPulmonary resuscitation with Argon (CPAr): A protocol for a randomised controlled multicentre clinical trial.

Giuseppe Ristagno, Lidia Staszewsky, Giulia Merigo...

https://pubmed.ncbi.nlm.nih.gov/41079544