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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005795
Receipt No. R000006854
Scientific Title A prospective observational study about regional cerebral oxygen saturation in patients for critical condition
Date of disclosure of the study information 2011/06/16
Last modified on 2011/06/19

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Basic information
Public title A prospective observational study about regional cerebral oxygen saturation in patients for critical condition
Acronym SENRI rSO2 study
Scientific Title A prospective observational study about regional cerebral oxygen saturation in patients for critical condition
Scientific Title:Acronym SENRI rSO2 study
Region
Japan

Condition
Condition Critical condition including cardiac arrest
Classification by specialty
Cardiology Emergency medicine Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the capability of regional brain oxygen saturation (rSO2) obtained immediately on hospital arrival to predict neurological outcomes in patients after out-of hospital cardiac arrest.
Basic objectives2 Others
Basic objectives -Others prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes rSO2, the clinical background, management, and outcomes of acute coronary syndrome
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with cardiac arrest on arrival after out-of hospital cardiac arrest, or patients with return to spontaneous circulation and comatose on arrival after out-of hospital cardiac arrest
Key exclusion criteria Out-of hospital cardiac arrest from a traumatic origin with uncontrolled bleeding, or patients with previous completion of a "Do Not Attempt Resuscitation" form
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noritoshi Ito
Organization Osaka Saiseikai Senri Hospital
Division name Senri Critical Care Medical Center
Zip code
Address 1-1-6 Tsukumodai Suita Osaka
TEL 06-6871-0121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noritoshi Ito
Organization Osaka Saiseikai Senri Hospital
Division name Senri Critical Care Medical Center
Zip code
Address 1-1-6 Tsukumodai Suita Osaka
TEL 06-6871-0121
Homepage URL
Email

Sponsor
Institute Osaka Saiseikai Senri Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪府済生会千里病院 救命救急センター(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 1. N Ito, S Nanto, K Nagao, T Hatanaka, T Kai. Regional Cerebral Oxygen Saturation Predicts Poor Neurological Outcome in Patients with Out-of-Hospital Cardiac Arrest. Resuscitation2010;81(12):1736-1737.
2. N Ito, et al. Regional Brain Oxygen Saturation as a Novel Index of Neurological Outcomes in Patients With Out-of-Hospital Cardiogenic Cardiac Arrest. ACC2010, Atlanta, Georgia
3. N Ito, et al. Regional Cerebral Oxygen Saturation as a Novel Index of Brain Resuscitation in Patients with Out-of-Hospital Cardiac Arrest. AHA2010, Chicago, Illinois
4. N Ito, et al. Regional Cerebral Oxygen Saturation: A Novel Index for Prompt Clinical Outcome Prediction before Starting Extracorporeal Cardiopulmonary Resuscitation in Out of Hospital Cardiac Arrest Patients. ACC2011, New Orleans, Louisiana
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
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2009 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The Senri rSO2 study is a prospective, single-center observational study designed to collect and analyze the rSO2 data, demographic, procedural, outcome data, and blood analysis data in patients with OHCA transported to Osaka Saiseikai Senri hospital in the north Osaka region of Japan. In addition to rSO2 data, physicians recorded data on revised Utstein cardiac arrest data collection form (Circulation. 2004;110:3385-3397.) and therapeutic procedures including post cardiac arrest interventions during patient hospitalization and clinical outcomes at hospital discharge.

Management information
Registered date
2011 Year 06 Month 16 Day
Last modified on
2011 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006854

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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