UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032940 |
|---|---|
| Receipt number | 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 11:41:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ttakihara@gmail.com
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
