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Early Restricted Oxygen Therapy after Resuscitation from Cardiac Arrest trial

Early Restricted Oxygen Therapy after Resuscitation from Cardiac Arrest trial - ER-OXYTRAC trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046914
Enrollment
1000
Registered
2022-02-14
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post cardiac arrest syndrome

Interventions

Restricted oxygen administration (Intervention): Titration of FiO2 with target SpO2 of 94-95% within 12 hours after return of spontaneous circulation Regular oxygen administration (Control): Titration

Sponsors

Japanese Association for Acute Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Non-traumatic out-of- and in-hospital cardiac arrest Return of spontaneous circulation in hospital

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Cerebral Performance Category (CPC) at 90 days after the study intervention

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactRyo Yamamoto

Keio University School of Medicine Department of Emergency and Critical Care Medicine

ryoyamamoto@keio.jp03-3225-1323

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026