UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059897 |
|---|---|
| Receipt number | R000068496 |
| Scientific Title | Sulfur metabolism in acute respiratory distress syndrome.: An observational study. |
| Date of disclosure of the study information | 2025/11/28 |
| Last modified on | 2025/11/27 12:17:21 |
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Basic information
Public title
Sulfur metabolism in acute respiratory distress syndrome.: An observational study.
Acronym
Sulfur metabolism in acute respiratory distress syndrome.: An observational study.
Scientific Title
Sulfur metabolism in acute respiratory distress syndrome.: An observational study.
Scientific Title:Acronym
Sulfur metabolism in acute respiratory distress syndrome.: An observational study.
Region
| Japan |
Condition
Condition
Acute respiratory distress syndrome
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore the role of sulfur metabolism in the mechanism of acute respiratory distress syndrome.
Basic objectives2
Others
Basic objectives -Others
To evaluate the changes of reactive sulfur species in tracheal sputum of patients with acute respiratory distress syndrome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of reactive sulfur species in tracheal sputum of patients with acute respiratory distress syndrome.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient group (ARDS group)
Patients who meet all of the following criteria:
1. Diagnosed with ARDS due to pneumonia
2. Severe respiratory failure (arterial partial pressure of oxygen /fraction of inspired oxygen ratio; P/F ratio < 200)
3. Receiving invasive mechanical ventilation via endotracheal intubation
Control group (Non-ARDS group)
Patients who meet all of the following criteria:
1. Patients receiving invasive mechanical ventilation via endotracheal intubation without developing ARDS
2. Patients without underlying chronic respiratory diseases
Key exclusion criteria
Patient group (ARDS group)
1. Patients with primary lung cancer
2. Patients with chronic obstructive pulmonary disease (COPD)
3. Patients with interstitial lung disease
Control group (Non-ARDS group)
1. Patients with primary lung cancer
2. Patients with chronic obstructive pulmonary disease (COPD)
3. Patients with interstitial lung disease
4. Patients with bacterial or viral pneumonia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Tojo |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457872800
ktojo@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Tojo |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
0457872800
Homepage URL
ktojo@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Takeda Science Foundation, Medtronic Academic Support
IRB Contact (For public release)
Organization
The Yokohama City University Ethics Research Committee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel
0457872800
rinri@yokohama-cu.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
| 2025 | Year | 11 | Month | 28 | 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
| 2025 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study explores the role of sulfur metabolism in ARDS, by evaluating the changes of reactive sulfur species in tracheal sputum of patients.
Management information
Registered date
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068496
