UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046914 |
|---|---|
| Receipt number | R000053527 |
| Scientific Title | Early Restricted Oxygen Therapy after Resuscitation from Cardiac Arrest trial |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2023/07/27 15:05:48 |
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Basic information
Public title
Early Restricted Oxygen Therapy after Resuscitation from Cardiac Arrest trial
Acronym
ER-OXYTRAC trial
Scientific Title
Early Restricted Oxygen Therapy after Resuscitation from Cardiac Arrest trial
Scientific Title:Acronym
ER-OXYTRAC trial
Region
| Japan |
Condition
Condition
Post cardiac arrest syndrome
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate whether early restricted oxygen administration with lower target for peripheral oxygen saturation (SpO2) is associated with better neurological outcomes in patients with post cardiac arrest syndrome. The hypothesis is that restricted oxygen administration with a target SpO2 of 94-95% within 12 hours after return of spontaneous circulation is associated with better neurological outcomes, compared with oxygen administration with target SpO2 equal to or higher than 98%.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Cerebral Performance Category (CPC) at 90 days after the study intervention
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Restricted oxygen administration (Intervention): Titration of FiO2 with target SpO2 of 94-95% within 12 hours after return of spontaneous circulation
Interventions/Control_2
Regular oxygen administration (Control): Titration of FiO2 with target SpO2 equal to or higher than 98% within 12 hours after return of spontaneous circulation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non-traumatic out-of- and in-hospital cardiac arrest
Return of spontaneous circulation in hospital
Key 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
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3225-1323
ryoyamamoto@keio.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yamamoto |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3225-1323
Homepage URL
https://www.jaam.jp/jaamer-oxytrac_trial/index.html
ryoyamamoto@keio.jp
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学病院（東京都）
大阪医科薬科大学附属病院（大阪府）
東京医科歯科大学医学部附属病院（東京都）
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
The datasets analyzed during the current study and statistical code will be available.
IPD sharing Plan description
After all the ancillary analyses by the trial group, the datasets analyzed during the current study and statistical code are available from the corresponding author on reasonable request.
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053527
