UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015479
Receipt number R000017992
Scientific Title Presumption of RESuscitation for Sustaining cerebral Oxidation : observational cohort study
Date of disclosure of the study information 2014/11/01
Last modified on 2017/06/30 15:29:25

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Basic information

Public title

Presumption of RESuscitation for Sustaining cerebral Oxidation
: observational cohort study

Acronym

PRESS study

Scientific Title

Presumption of RESuscitation for Sustaining cerebral Oxidation
: observational cohort study

Scientific Title:Acronym

PRESS study

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 verify the usefulness of rSO2 value monitoring under CPR to OHCA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship mean arterial pressure and neurological outcomes and regional oxygen saturation

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

The patient with OHCA at the admission to hospital and carried out arterial pressure monitoring during CPR

Key exclusion criteria

Less than 18 years old
Cardiac arrest due to traumatic accident
The patients with DNAR

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideto Yasuda

Organization

Japanese Red Cross Musashino hospital

Division name

Department of emergency and critical care medicine

Zip code


Address

1-26-1 kyounanchou, musashino-shi, tokyo, Japan

TEL

0422-32-3111

Email

yasudahideto@me.com


Public contact

Name of contact person

1st name
Middle name
Last name Hideto Yasuda

Organization

Japanese Red Cross Musashino hospital

Division name

Department of emergency and critical care medicine

Zip code


Address

1-26-1 kyounanchou, musashino-shi, tokyo, Japan

TEL

0422-32-3111

Homepage URL


Email

yasudahideto@me.com


Sponsor or person

Institute

Japanese Red Cross Musashino hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese Red Cross Musashino hospital

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



Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 01 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

Completed

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 11 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

none


Management information

Registered date

2014 Year 10 Month 20 Day

Last modified on

2017 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017992


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name