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Early Restricted Oxygen Therapy after Resuscitation from Cardiac Arrest trial

Phase 3
Recruiting
Conditions
Post cardiac arrest syndrome
Registration Number
JPRN-UMIN000046914
Lead Sponsor
Japanese Association for Acute Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1000
Inclusion Criteria

Not provided

Exclusion Criteria

Spontaneous circulation on hospital arrival No ventilator use for oxygen administration after return of spontaneous circulation (ROSC) GCS equal to or higher than 8 at the time of ROSC ECMO use at the time of ROSC Survival longer than 24 hours after ROSC is not expected Cardiac arrest due to intracranial diseases Poor neurological function before cardiac arrest (Cerebral Performance Category =3 or 4) COVID-19 requiring medications designated for COVID-19 Withholding or withdrawing critical care at the time of ROSC Severe comorbidity that requires strict titration of oxygen, such as chronic lung diseases and congenital diseases Cardiac arrest due to intoxication is suspected Patients in whom SpO2 cannot be measured correctly Patients who participated in other clinical trials that require a therapeutic intervention Patients who need to be arrested, detained, or put in custody by law enforcement or legal agencies Patients who refuse to participate in the trial Patients deemed by a clinical physician to be ineligible to participate

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cerebral Performance Category (CPC) at 90 days after the study intervention
Secondary Outcome Measures
NameTimeMethod
30-day mortality, 90-day mortality, hospital-, ICU-, ventilator-, RRT-, and oxygen-free days to day 90, clinical frailty scale at 90 days, hyperoxemia equal to or higher than 300 mmHg in arterial blood within 12 hours, and hypoxia less than 60 mmHg in arterial blood within 12 hours.
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