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/41079544Actively Recruiting
Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-09-17
120
Participants Needed
9
Research Sites
13 weeks
Total Duration
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
CardioPulmonary Resuscitation With Argon (CPAr) Trial
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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
G
Giulia Merigo, MSc
A
Antonella Vasamì
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Giuseppe Ristagno, Lidia Staszewsky, Giulia Merigo...
https://pubmed.ncbi.nlm.nih.gov/41079544