UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019701
Receipt number R000022756
Scientific Title A multicenter, prospective observational study for the epidemiology of acute lung injury and acute respiratory distress syndrome
Date of disclosure of the study information 2015/11/16
Last modified on 2020/11/12 10:34:19

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Basic information

Public title

A multicenter, prospective observational study for the epidemiology of acute lung injury and acute respiratory distress syndrome

Acronym

Epidemiology of ALI/ARDS (FORECAST ARDS)

Scientific Title

A multicenter, prospective observational study for the epidemiology of acute lung injury and acute respiratory distress syndrome

Scientific Title:Acronym

Epidemiology of ALI/ARDS (FORECAST ARDS)

Region

Japan


Condition

Condition

Acute lung injury, Acute respiratory distress syndrome

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to elucidate the epidemiology, pathophysiology/pathogenesis, and diagnosis/treatment of acute lung injury (ALI) / acute respiratory distress syndrome (ARDS) diagnosed by the AECC and Berlin definitions.

Basic objectives2

Others

Basic objectives -Others

28-day and hospital mortality

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The epidemiology of ALI/ARDS (hospital mortality)

Key secondary outcomes

1. The pathophysiology and pathogenesis of ALI/ARDS
2. The diagnosis and therapeutic methods of ARDS


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who met the definition of ALI/ARDS according to the AECC (American European Consensus Conference)

Key exclusion criteria

None

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name GANDO

Organization

Hokkaido University Graduate School of Medicine

Division name

Acute and Critical Care Medicine

Zip code

060-8638

Address

N15W7, Kita-ku, Sapporo

TEL

+81-11-706-7377

Email

gando@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Shuta
Middle name
Last name Fukuda

Organization

Japanese Association for Acute Medicine

Division name

Office

Zip code

113-0033

Address

3-3-12, Hongo, Bunkyo-ku, Tokyo

TEL

+81-3-5840-9870

Homepage URL

http://www.jaam.jp/html/jaamforecast/index.html

Email

jaam-10@umin.ac.jp


Sponsor or person

Institute

Japanese Association for Acute Medicine

Institute

Department

Personal name



Funding Source

Organization

Japanese Association for Acute Medicine, Japan Society for the Promotion of the Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Hospital Clinical Research and Medical Innovation Center

Address

N14W5, Kita-ku, Sapporo

Tel

+81-11-701-7636

Email

crjimu@huhp.hokudai.ac.jp


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

2015 Year 11 Month 16 Day


Related information

URL releasing protocol

http://www.jaam.jp/html/jaamforecast/index.html

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31348148

Number of participants that the trial has enrolled

166

Results

CONCLUSIONS: Our study included a greater percentage of patients with ARDS with high severity and found that the overall mortality was 38%. The management of ARDS in Japan was characterized by high the utilization rate of glucocorticoids, which was positively associated with mortality.

Results date posted

2020 Year 05 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 05 Month 01 Day

Baseline Characteristics

PURPOSE: Acute respiratory distress syndrome (ARDS) remains a major cause of death. Epidemiology should be continually examined to refine therapeutic strategies for ARDS. We aimed to elucidate demographics, treatments, and outcomes of ARDS in Japan.

Participant flow

METHODS: This is a prospective cohort study for ARDS. We included adult patients admitted to intensive care units through emergency and critical care departments who satisfied the American-European Consensus Conference (AECC) acute lung injury (ALI) criteria. In addition, the fulfillment of the Berlin definition was assessed. Logistic regression analyses were used to examine the association of independent variables with outcomes.

Adverse events

Not applicable

Outcome measures

RESULTS: Our study included 166 patients with AECC ALI from 34 hospitals in Japan; among them, 157 (94.6%) fulfilled the Berlin definition. The proportion of patients with PaO2/FIO2 lower than 100, patients under invasive positive pressure ventilation (IPPV), and in-hospital mortality was 39.2%, 92.2%, and 38.0% for patients with AECC ALI and 38.9%, 96.8%, and 37.6% for patients with Berlin ARDS, respectively. The area of lung infiltration was independently associated with outcomes of ARDS. Low-mid-tidal volume ventilation was performed in 75% of patients under IPPV. Glucocorticoid use was observed in 54% patients, and it was positively associated with mortality.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 06 Month 05 Day

Date of IRB

2016 Year 10 Month 28 Day

Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2017 Year 05 Month 31 Day

Date of closure to data entry

2017 Year 07 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

Study design: Prospective cohort study

Patients enrollment method; We recruit all patients who visit ER or are admitted to a ward of the participated hospitals between January 1 and December 31, 2016, fulfilling the AECC ALI criteria, butnot any of exclusion criteria.

Data collection: Relationships between patients' background factors (age, gender, comorbidities, etc), predisposing diseases, disease severity (P/F ratio), laboratory findings, organ dysfunction, etc and outcome (hospital mortality, 28-day mortality, hospital stay, ventilator-free days, etc)


Management information

Registered date

2015 Year 11 Month 09 Day

Last modified on

2020 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name