UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008495
Receipt number 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 10:06:07

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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 or person

Institute

Keio University School of Medicine

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

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

Value
https://center6.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