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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008495
Receipt No. R000009987
Scientific Title The prospective observational multi-center study about lactate clearance and regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Date of disclosure of the study information 2012/07/23
Last modified on 2015/01/23

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Basic information
Public title The prospective observational multi-center study about lactate clearance and regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Acronym Prediction of neurological Outcomes in patients Post cardiac arrest with Lactate clearance trial (J-POP Lac trial)
Scientific Title The prospective observational multi-center study about lactate clearance and regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Scientific Title:Acronym Prediction of neurological Outcomes in patients Post cardiac arrest with Lactate clearance trial (J-POP Lac trial)
Region
Japan

Condition
Condition Out of hospital cardiac arrest (OHCA)
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 investigate the capability of lactate clearance and regional brain oxygen saturation (rSO2) obtained immediately on arrival at the hospital to predict neurological outcomes in patients after out-of hospital cardiac arrest.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes CPC (Glasgow-Pittsburgh Cerebral Performance Categories) after 90 days from out-of hospital cardiac arrest.
Key secondary outcomes CPC (Glasgow-Pittsburgh Cerebral Performance Categories) at hospital discharge

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 traumatic origin with uncontrolled bleeding, or patients with previous completion of a Do Not Attempt Resuscitation form
Death within 16 hours from hospital arrival
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hori
Organization Keio University School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 35 Shinanomachi Shinjyukuku Tokyo
TEL 03-3353-1211
Email keilinda0714@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kei Hayashida
Organization Keio University School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 35 Shinanomachi Shinjyukuku Tokyo
TEL 03-3353-1211
Homepage URL
Email keilinda@z6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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

Other related organizations
Co-sponsor Department of Primary Care and Emergency Medicine, Kyoto University Graduate School of Medicine
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)
京都大学医学研究科 初期診療・救急医学分野(京都府)
慶應義塾大学 救急科(東京都)
国立病院機構 京都医療センター(京都府)
済生会横浜市東部病院 (神奈川県)
東北大学 高度救命救急センター (宮城県)
藤沢市民病院 (神奈川県)
三重大学医学部附属病院 救命救急センター (三重県)
岐阜大学医学部附属病院 高度救命救急センター (岐阜県)
武蔵野赤十字病院 救命救急センター (東京都)
大阪市立総合医療センター 救命救急センター (大阪府)
聖路加国際病院 救命救急センター (東京都)
Osaka Saiseikai Senri Hospital Senri Critical Care Medical Center
Kyoto University Graduate School of Medicine Department of Primary Care and Emergency Medicine
Keio University School of Medicine Department of Emergency and Critical Care Medicine
National Hospital Organization Kyoto Medical Center Critical Care Medical Center and Department of Cardiology
Saiseikai Yokohamashi Tobu Hospital Critical Care Medical Center
Tohoku University Hospital Advanced Emergency Center
Fujisawa City Hospital Critical Care Medical Center and Department of Cardiology
Mie University Hospital Critical Care Medical Center
Gifu University Hospital Advanced Critical Care Medical Center
Japanese Red Cross Musashino Hospital Critical Care Medical Center
Osaka City General Hospital  Critical Care Medical Center
St Luke’s International Hospital Critical Care Medical Center and Department of Cardiology


Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 23 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
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 23 Day
Last follow-up date
2013 Year 10 Month 31 Day
Date of closure to data entry
2014 Year 01 Month 31 Day
Date trial data considered complete
2014 Year 04 Month 30 Day
Date analysis concluded
2014 Year 07 Month 31 Day

Other
Other related information This study is prospective observational multi center study. In this study receiver operating characteristic (ROC) analysis is performed to evaluate the diagnostic accuracy of blood lactate clearance in early phase (blood lactate on hospital arrival; blood lactate after 8-16 hours from hospital arrival / (blood lactate on hospital arrival) and rSO2 in predicting good neurological outcome (CPC1,2) in patients 90days after out-of hospital cardiac arrest.

Management information
Registered date
2012 Year 07 Month 23 Day
Last modified on
2015 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009987

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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