Clinical trial • Phase I/II|Phase II • Cardiology
Argon; Oxygen for Cardiac arrest
Phase I/II|Phase II trial of Argon; Oxygen for Cardiac arrest.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Cardiac arrest
- Trial Stage
- Phase I/II|Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-09-2024
- First CTIS Authorization Date
- 07-10-2024
Trial design
Randomised, open-label, control-standard: ventilation with a fio2 of 30% (air/o2 standard ventilation) continued for 4 hours (product listed as oxygen). Phase I/II|Phase II trial across 11 sites in Italy.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control-standard: ventilation with a FiO2 of 30% (Air/O2 standard ventilation) continued for 4 hours (product listed as OXYGEN).
- Target Sample Size
- 120
- Trial Duration For Participant
- 180
Eligibility
Recruits 120 adults.
- Pregnancy Exclusion
- pregnancy
Inclusion criteria
- {"criterion_text":"- witnessed non-traumatic OHCA of presumably cardiac etiology with a presenting shockable rhythm"}
- {"criterion_text":"- age ≥ 18 years"}
- {"criterion_text":"- unconsciousness after return of spontaneous circulation (ROSC)"}
- {"criterion_text":"- duration of CPR ≤ 40 mins"}
- {"criterion_text":"- Initiation of study intervention ≤ 4 hrs from ROSC"}
- {"criterion_text":"- stable SaO2 ≥ 94% (according to the physician’s criteria), with a FiO2 of 30%"}
Exclusion criteria
- {"criterion_text":"- age < 18 years"}
- {"criterion_text":"- initiation of the study intervention > 4 hrs from ROSC"}
- {"criterion_text":"- participation to another clinical trial"}
- {"criterion_text":"- non-witnessed CA"}
- {"criterion_text":"- CA of traumatic origin"}
- {"criterion_text":"- non-presumably cardiac cause"}
- {"criterion_text":"- non-shockable presenting rhythm (pulseless electrical activity and asystole)"}
- {"criterion_text":"- women of childbearing potential defined as younger of 50 years"}
- {"criterion_text":"- pregnancy"}
- {"criterion_text":"- known terminal illness"}
- {"criterion_text":"- pre-CA cerebral performance category (CPC) ≥ 3"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 48 h Serum Neuron Specific Enolase (NSE) concentration for evaluation of Ar activity on neuronal preservation.","definition_or_measurement_approach":"Serum Neuron Specific Enolase (NSE) concentration measured at 48 hours after ROSC."}
Secondary endpoints
- {"endpoint_text":"- hs-cTnT plasma concentration for evaluation of Ar activity on myocardial preservation;","definition_or_measurement_approach":"High-sensitivity cardiac troponin T (hs-cTnT) plasma concentration measurements to evaluate myocardial preservation."}
- {"endpoint_text":"- Brain imaging (MRI with DWI and DTI, in patients that remain comatose), for evaluation of Ar activity on neuronal preservation;","definition_or_measurement_approach":"Brain MRI including DWI and DTI sequences in patients who remain comatose to assess neuronal preservation."}
- {"endpoint_text":"- Multiorgan function (circulating biomarkers);","definition_or_measurement_approach":"Assessment of multiorgan function via circulating biomarkers (unspecified biomarkers as per protocol)."}
- {"endpoint_text":"- Survival and CPC score up to 6 months, for evaluation of functional outcome.","definition_or_measurement_approach":"Survival status and Cerebral Performance Category (CPC) score assessed up to 6 months post-ROSC."}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 46
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 120
Italy
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 595
- Number Of Sites
- 11
- Number Of Participants
- 120
Sites
- Site Name
- IRCSS Ospedale Policlinico San Martino
- Department Name
- Anestesia e Rianimazione
- Contact Person Name
- Chiara Robba
- Contact Person Email
- chiara.robba@unige.it
- Site Name
- Ospedale Santa Chiara
- Department Name
- Rianimazione Generale, Anestesia e Rianimazione 1,
- Contact Person Name
- Alberto Cucino
- Contact Person Email
- alberto.cucino@apss.tn.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Clinica di Anestesia e Rianimazione Generale, Respiratoria e del Trauma Maggiore
- Contact Person Name
- Abele Donati
- Contact Person Email
- a.donati@staff.univpm.it
- Site Name
- Azienda Ospedaliera Friuli Occidentale, ASFO Pordenone
- Department Name
- SC Anestesia e Rianimazione
- Contact Person Name
- Tommaso Pellis
- Contact Person Email
- thomas.pellis@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione
- Contact Person Name
- Claudio Sandroni
- Contact Person Email
- Claudio.Sandroni@unicatt.it
- Site Name
- Ospedale Maggiore Carlo Alberto Pizzardi – AUSL Bologna, Bologna (IT)
- Department Name
- UOC Rianimazione ed Emergenza Territoriale 118 –
- Contact Person Name
- Lorenzo Gamberini
- Contact Person Email
- lorenzo.gamberini@ausl.bologna.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UOC Anestesia e Terapia Intensiva Adulti
- Contact Person Name
- Giuseppe Ristagno
- Contact Person Email
- giuseppe.ristagno@policlinico.mi.it
- Site Name
- Azienda Ospedaliero - Universitaria di Parma
- Department Name
- Struttura Complessa Terapia Intensiva Anestesia e Rianimazione
- Contact Person Name
- Edoardo Picetti
- Contact Person Email
- edoardopicetti@hotmail.com
- Site Name
- Arcispedale S. Maria Nuova in Reggio Emilia
- Department Name
- Rianimazione
- Contact Person Name
- Giovanni Salati
- Contact Person Email
- Giovanni.Salati@ausl.re.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Emergenza Urgenza - Anestesia e Rianimazione
- Contact Person Name
- Giuseppe Foti
- Contact Person Email
- giu.foti@irccs-sangerardo.it
- Site Name
- Azienda Sanitaria Universitaria Giuliano Isontina
- Department Name
- Anestesia e Rianimazione
- Contact Person Name
- Erik Roman Pognuz
- Contact Person Email
- romanpognuz.erik@gmail.com
Sponsor
Primary sponsor
- Full Name
- Istituto Di Ricerche Farmacologiche Mario Negri
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Italy
Third parties
- {"country":"Italy","full_name":"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Argon/Oxygen mixture
- Active Substance
- Argon; Oxygen
- Modality
- Small molecule
- Routes Of Administration
- Inhalation (gas)
- Route
- INHALATION GAS
- Starting Dose
- Ar 70% / O2 30% ventilation for 4 hours
- Dose Levels
- 70% Ar / 30% O2 (single 4-hour exposure)
- Frequency
- Single 4-hour treatment (administration immediately post-ROSC)
- Maximum Dose
- 70% (Ar)
- Investigational Product Name
- OXYGEN
- Active Substance
- Nitrous oxide; Oxygen
- Modality
- Small molecule
- Routes Of Administration
- Inhalation (gas)
- Route
- INHALATION GAS
- Starting Dose
- Ventilation with FiO2 of 30% (standard Air/O2) for 4 hours
- Dose Levels
- 30% O2 (FiO2 30%) for 4 hours
- Frequency
- Continuous ventilation for 4 hours
- Maximum Dose
- 30% (O2)
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