UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014418
Receipt number R000016775
Scientific Title Study for Correlation of organ injury with transition of adiponectin in acute and critical illness
Date of disclosure of the study information 2020/01/01
Last modified on 2020/01/14 19:00:51

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Basic information

Public title

Study for Correlation of organ injury with transition of adiponectin in acute and critical illness

Acronym

RESPECT ALL Study

Scientific Title

Study for Correlation of organ injury with transition of adiponectin in acute and critical illness

Scientific Title:Acronym

RESPECT ALL Study

Region

Japan


Condition

Condition

acute and critical illness

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Nephrology Infectious disease Emergency medicine
Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of circulating biomarkers in acute and critical illness.

Basic objectives2

Others

Basic objectives -Others

Discovery of circulating biomarker predicting severity and prognosis in the acute and critical illness.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Discovery of circulating biomarker predicting severity and prognosis in the acute and critical illness.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects who were hospitalized in emergency and agreed with study protocol.

Key exclusion criteria

(1) Subjects who were judged inadequate for the study by the attending physician.
(2) Subjects who passed on day 8 after hospitalization.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iichiro Shimomura

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Metabolic Medicine

Zip code


Address

2-2-B5, Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3737

Email

ichi@endmet.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norikazu Maeda

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Metabolic Medicine

Zip code


Address

2-2-B5, Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3737

Homepage URL


Email

norikazu_maeda@endmet.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Metabolic Medicine, Graduate School of Medicine, Osaka University

Institute

Department

Personal name



Funding Source

Organization

Department of Metabolic Medicine, Graduate School of Medicine, Osaka University

Organization

Division

Category of Funding Organization

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

2020 Year 01 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

2013 Year 08 Month 15 Day

Date of IRB

2013 Year 08 Month 15 Day

Anticipated trial start date

2013 Year 09 Month 02 Day

Last follow-up date

2018 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete

2018 Year 02 Month 28 Day

Date analysis concluded



Other

Other related information

Examination of adipocytokines, inflammatory cytokines, and oxidative stresses


Management information

Registered date

2014 Year 06 Month 29 Day

Last modified on

2020 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016775


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name