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CardioPulmonary Resuscitation With Argon (CPAr) Trial

Study acronym: CPAr
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 17, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Secondary endpoints: details revised at 4 of 6 entriesv5
  2. Notable Phase: Not applicable to Phase 2v4 Show 6 more changesShow less
    • Enrollment target: 50 to 120
    • Primary endpoint revised
    • Study sites: 4 to 9
    • Interventions: Noble gas Argon (Other) to Noble gas Argon (Drug)
    • Secondary endpoints revised (6)
    • Study description shortened, about 76 words
  3. Notable Primary completion date: Mar 30, 2025 to Mar 31, 2026
    • Study completion date: Sep 16, 2025 to Jun 30, 2026
    v3
  4. Notable Primary completion date: Jun 30, 2023 to Mar 30, 2025v2 Show 5 more changesShow less
    • Study sites: 2 to 4
    • Study completion date: Dec 31, 2023 to Sep 16, 2025
    • Eligibility criteria revised
    • Secondary endpoints: 5 to 6
    • Study description shortened, about 1 word
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05482945
Lead Sponsor Mario Negri Institute for Pharmacological Research
Conditions
(from sponsor)
Cardiac Arrest, Out-Of-Hospital, Cardiac Arrest With Successful Resuscitation
Related terms Heart Arrest, Out-of-Hospital Cardiac Arrest
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov