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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032940
Receipt No. R000037555
Scientific Title A prospective cohort study of acute respiratory failure in idiopathic interstitial pneumonias
Date of disclosure of the study information 2018/06/14
Last modified on 2019/07/10

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Basic information
Public title A prospective cohort study of acute respiratory failure in idiopathic interstitial pneumonias
Acronym AREFIP study
Scientific Title A prospective cohort study of acute respiratory failure in idiopathic interstitial pneumonias
Scientific Title:Acronym AREFIP study
Region
Japan

Condition
Condition Idiopathic interstitial pneumonias (IIPs)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Prospective study of patients with acute exacerbation or acute respiratory failure, acute exacerbation of chronic respiratory failure during the course of idiopathic interstitial pneumonias
Basic objectives2 Others
Basic objectives -Others Prospective analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Proportion and clinical characteristics of IIP cases with acute respiratory failure caused by a factor(s) other than acute exacerbation
2. Clinical characteristics, treatment responses, and prognosis of the patients with acute exacerbation according to a new classification of the severity
3. Clinical characteristics and prognosis of responders and non-responders to glucocorticoid treatment of acute exacerbation
4. Long-term QOL, respiratory function, prevalence of re-exacerbation, and prognosis observation of acute exacerbation survivors
5. Prevalence of acute exacerbation due to specific triggers (drug, surgery, infection, etc.) and their treatment response and prognosis
6. Factors associated with prognosis of acute exacerbation
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 1. Pre-existing idiopathic interstitial pneumonia is proved or suspected
2. Acute worsening or development of dyspnea within 1 month
3. Requirement for oxygen therapy to maintain SpO2 >90%, or increase in oxygen flow to maintain SpO2 >90% in cases under long-term oxygen therapy
4. New ground-glass opacity in the lungs on chest computed tomography
5. Written informed consent has been obtained
Key exclusion criteria 1. Connective tissue disease-related interstitial lung disease (CTD-ILD)
2. Hypersensitivity pneumonia
3. Cryptogenic organizing pneumonia
4. Radiation-induced lung injury
5. Pulmonary lymphangitic carcinomatosis
6. Patients who cannot perform the tests conducted in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Asano
Organization Tokai University School of Medicine
Division name Division of Pulmonary Medicine, Department of Medicine
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
TEL +81463931121
Email ko-asano@tokai-u.jp

Public contact
Name of contact person
1st name Takahisa
Middle name
Last name Takihara
Organization Tokai University School of Medicine
Division name Division of Pulmonary Medicine, Department of Medicine
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
TEL +81463931121
Homepage URL
Email ttakihara@gmail.com

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization Tokai University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University Hospital
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
Tel +81463931121
Email tokai-rinsho@ml.tokai-u.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 東海大学医学部付属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 14 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 18 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 06 Month 10 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037555

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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