Clinical Trials Logo

Clinical Trial 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 aim of the CPAr trial is to evaluate feasibility and safety of Ar/O2 ventilation in patients resuscitated from CA. Activity endpoints will be also evaluated to assess effects of Ar.


Clinical Trial Description

The trial is a multicenter, randomized, controlled, single blinded, phase I and pre marketing study in patients resuscitated from Out-of-hospital cardiac arrest (OHCA). The adoption of a randomized design in a phase I trial aiming at a safety assessment of a new ventilation mixture in a very critical population is justified and necessary in the absence of reliably comparable populations on which to base estimates of a potential excess of adverse events/side effects. All eligible patients will be treated in full and documented compliance with the European ResuscitationCouncil (ERC)/European Society of Intensive Care Medicine (international guidelines and local post resuscitation protocols). Since a reliable estimate of the incidence and characteristics of the clinical events assumed as endpoints is not available in the literature, a randomized assignment is the only way to ensure a strict comparability for both the periods of data collection of safety end points (to be assessed blindly by the events Committee), the four hours of duration of study treatment, and the longer period of possibly related clinical events during 6 months follow up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05482945
Study type Interventional
Source Mario Negri Institute for Pharmacological Research
Contact Lidia Staszewsky, MD
Phone 02390141
Email lidia.staszewsky@marionegri.it
Status Recruiting
Phase N/A
Start date May 30, 2022
Completion date September 16, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03700203 - Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance
Not yet recruiting NCT05325385 - Ventricular Fibrillation Following Out-of-hospital Cardiac Arrest
Withdrawn NCT05236920 - Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT) N/A
Enrolling by invitation NCT05830422 - Prediction of Delayed Cognitive Impairment in Cardiac Arrest Survivors With Good Neurological Outcomes
Recruiting NCT04876222 - Direct or Subacute Coronary Angiography in Patients With Out of Hospital Cardiac Arrest Without Coma. N/A
Completed NCT03112486 - Out-of-hospital Cardiac Arrest (OHCA) Biomarkers
Recruiting NCT03826524 - Epinephrine Dose: Optimal Versus Standard Evaluation Trial Phase 4
Completed NCT04891380 - BCG Biosensor and Non- and Invasive Monitoring During Emergency Medicine Cases, a Prospective Feasibility Study N/A
Recruiting NCT04217551 - Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients N/A
Enrolling by invitation NCT05013333 - AED 3 Post-Approval Study N/A
Completed NCT04791995 - Resuscitation and Capillary Reperfusion
Recruiting NCT06334718 - Drone Delivered Defibrillators (The 3D Project).
Recruiting NCT05588024 - International Device Assisted Controlled Sequential Elevation CPR Registry
Withdrawn NCT04286204 - New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial N/A
Recruiting NCT06249893 - Feasibility of Doppler Ultrasound for Pulse Detection in Out-of-Hospital Cardiac Arrest Patients
Recruiting NCT06165081 - The Association Between Post-resuscitation Time Series Management in the Emergency Department and Short-term Outcomes for Out-of-hospital Cardiac Arrest Patients
Recruiting NCT05908500 - Overcoming Barriers to Performing CPR Using a Novel, Interactive CPR Game System N/A
Recruiting NCT04360070 - The Application of Ketamine for Sedation in Patients With Cardiac Arrest - - KetCat (KETamine in Cardiac ArresT) Study N/A
Completed NCT03464123 - Brain Oxygenation During Cardiopulmonary Resuscitation
Recruiting NCT04972526 - Resuscitative TEE Collaborative Registry