CardioPulmonary resuscitation with Argon (CPAr) trial

Phase 1

Active, not recruiting

Conditions: Cardiac Arrest
MedDRA version: 20.0Level: LLTClassification code 10019249Term: Heart arrestSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2018-003047-32-IT

Lead Sponsor: IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

Inclusion Criteria

1) witnessed non-traumatic OHCA of presumably cardiac etiology with a presenting shockable rhythm; (2) age = 18 years; (3) unconsciousness after return of spontaneous circulation (ROSC); (4) duration of CPR = 30 mins; (5) initiation of study intervention = 3 hrs from ROSC; (6) stable SaO2 = 94%, with a FiO2 of 30%.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

(1) age < 18 years; (2) non-witnessed CA; (3) CA of traumatic origin; (4) non-presumably cardiac cause; (5) non-shockable presenting rhythm (pulseless electrical activity and asystole); (6) pregnancy; (7) known terminal illness; (8) pre-CA cerebral performance category (CPC) = 3; (9) initiation of the study intervention > 3 hrs from ROSC; (10) partecipation to another clinical trial;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the CPAr trial is to evaluate feasibility and safety of Ar 70%/O2 30% ventilation in patients resuscitated from OHCA.;Secondary Objective: NA;Primary end point(s): a.The incidence, the timing, and the duration of the need to stop Ar 70% treatment in order to maintain the recommended SaO2.<br>b.The incidence of potentially Ar-attributable hemodynamic adverse events (i.e. arterial hypotension not responsive to fluids and/or vasoactive/inotropic drugs).;Timepoint(s) of evaluation of this end point: 1 MONTHS

Secondary Outcome Measures