search
Back to results

CardioPulmonary Resuscitation With Argon (CPAr) Trial (CPAr)

Primary Purpose

Cardiac Arrest, Out-Of-Hospital, Cardiac Arrest With Successful Resuscitation

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Noble gas Argon
Sponsored by
Mario Negri Institute for Pharmacological Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Cardiac arrest; Cardiopulmonary resuscitation; Argon.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ICU admission after resuscitation from witnessed non-traumatic out-of-hospital cardiac arrest (OHCA) of presumably cardiac etiology with a presenting shockable rhythm; age ≥ 18 years; unconsciousness after return of spontaneous circulation (ROSC); duration of CPR ≤ 30 mins; initiation of study intervention ≤ 3 hrs from ROSC; stable SaO2 ≥ 94% with a FiO2 of 30%.

Exclusion Criteria:

Non-witnessed CA; CA of traumatic origin or from a non-presumably cardiac cause; CA with a non-shockable presenting rhythm (pulseless electrical activity and asystole); female of childbearing potential defined as younger of 50 years; pregnancy; known terminal illness; pre-CA cerebral performance category (CPC) ≥ 3; initiation of the study intervention > 3 hrs from ROSC: participation to another clinical trial.

Sites / Locations

  • Ospedale San Gerado
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control-standard

Arm Description

Patients will be ventilated with a mixture of Ar 70%/O2 30% for 4 hours

Ventilation with a FiO2 of 30% in room air is continued for 4 hours.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
The incidence, the timing, and the duration of the need to stop Ar 70% treatment in order to maintain the SPO2> 90%. The incidence of potentially Ar-attributable hemodynamic adverse events (i.e. arterial hypotension not responsive to fluids and/or vasoactive/inotropic drugs).

Secondary Outcome Measures

Myocardial preservation
Ar effect on myocardial protection is assessed through measure of hs-cTnT release
Neuronal preservation
Ar effect on neuronal preservation is assessed through evaluation of NSE preservation and ultimately on survival (CPC score) will be evaluated.
Brain injury
Ar effect on brain injury is assessed through MRI (imaging)
Survival
effect of argon on survival after cardiac arrest (days)
Neurological recovery
Neurological functional recovery iassessed with the CPC score

Full Information

First Posted
July 26, 2022
Last Updated
July 28, 2022
Sponsor
Mario Negri Institute for Pharmacological Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05482945
Brief Title
CardioPulmonary Resuscitation With Argon (CPAr) Trial
Acronym
CPAr
Official Title
CardioPulmonary Resuscitation With Argon (CPAr) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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 the 1 month follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital, Cardiac Arrest With Successful Resuscitation
Keywords
Cardiac arrest; Cardiopulmonary resuscitation; Argon.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention (Ar/O2 or standard ventilation) is assigned to the patient using a centrally generated randomization plan, balanced by centre.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will be ventilated with a mixture of Ar 70%/O2 30% for 4 hours
Arm Title
Control-standard
Arm Type
No Intervention
Arm Description
Ventilation with a FiO2 of 30% in room air is continued for 4 hours.
Intervention Type
Other
Intervention Name(s)
Noble gas Argon
Intervention Description
Ventilation with Ar 70%/O2 30% in comatose patients resuscitated from OHCA with the use of an experimental mechanical ventilator.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
The incidence, the timing, and the duration of the need to stop Ar 70% treatment in order to maintain the SPO2> 90%. The incidence of potentially Ar-attributable hemodynamic adverse events (i.e. arterial hypotension not responsive to fluids and/or vasoactive/inotropic drugs).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Myocardial preservation
Description
Ar effect on myocardial protection is assessed through measure of hs-cTnT release
Time Frame
96 hours
Title
Neuronal preservation
Description
Ar effect on neuronal preservation is assessed through evaluation of NSE preservation and ultimately on survival (CPC score) will be evaluated.
Time Frame
96 hours
Title
Brain injury
Description
Ar effect on brain injury is assessed through MRI (imaging)
Time Frame
96 hours
Title
Survival
Description
effect of argon on survival after cardiac arrest (days)
Time Frame
1 month
Title
Neurological recovery
Description
Neurological functional recovery iassessed with the CPC score
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICU admission after resuscitation from witnessed non-traumatic out-of-hospital cardiac arrest (OHCA) of presumably cardiac etiology with a presenting shockable rhythm; age ≥ 18 years; unconsciousness after return of spontaneous circulation (ROSC); duration of CPR ≤ 30 mins; initiation of study intervention ≤ 3 hrs from ROSC; stable SaO2 ≥ 94% with a FiO2 of 30%. Exclusion Criteria: Non-witnessed CA; CA of traumatic origin or from a non-presumably cardiac cause; CA with a non-shockable presenting rhythm (pulseless electrical activity and asystole); female of childbearing potential defined as younger of 50 years; pregnancy; known terminal illness; pre-CA cerebral performance category (CPC) ≥ 3; initiation of the study intervention > 3 hrs from ROSC: participation to another clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lidia Staszewsky, MD
Phone
02390141
Ext
4508
Email
lidia.staszewsky@marionegri.it
First Name & Middle Initial & Last Name or Official Title & Degree
Antonella Vasamì
Phone
02390141
Ext
4450
Email
antonella.vasami@marionegri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Ristagno, MD, PhD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Gerado
City
Monza
State/Province
Milano
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Foti, MD
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Ristagno, MD,PhD
Email
giuseppe.ristagno@unimi.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CardioPulmonary Resuscitation With Argon (CPAr) Trial

We'll reach out to this number within 24 hrs