UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000019701
Receipt No. 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 (Ver. 14)

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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
Institute Japanese Association for Acute Medicine
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022756