UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005795 |
|---|---|
| Receipt number | 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 19:59:51 |
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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
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
Sponsor or person
Institute
Osaka Saiseikai Senri Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006854
| Research Plan | |
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