UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030846
Receipt No. R000035216
Scientific Title Nutrition-related factors associated with waiting list mortality in patients with interstitial lung disease
Date of disclosure of the study information 2018/01/17
Last modified on 2018/01/17

* 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 Nutrition-related factors associated with waiting list mortality in patients with interstitial lung disease
Acronym Factors associated with waitlist mortality
Scientific Title Nutrition-related factors associated with waiting list mortality in patients with interstitial lung disease
Scientific Title:Acronym Factors associated with waitlist mortality
Region
Japan

Condition
Condition interstitial lung disease
chronic respiratory disease
Classification by specialty
Pneumology Chest surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find nutrition-related markers with waiting list mortality
Basic objectives2 Others
Basic objectives -Others association with wait list mortality and body compositions, serum albumin and serum transthyretin
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to assess the relationship of nutrition-related factors with waiting list mortality
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 1. interstitial lung disease
Key exclusion criteria 1. severe comorbidities
2. lung transplantation from living donors during hospitalization before registration to JOTN
3. hospitalization for a second lung transplantation
4. registration at another hospital
5. failure to meet the JOTN criteria
6. severe mental disorders
7. alcoholism
8. smoking
9. incomplete data
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Harashima
Organization Kyoto University
Division name Diabetes, Endocrinology and Nutrition
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto
TEL 0757513560
Email harasima@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyofumi F. Chen-Yoshikawa
Organization Kyoto University
Division name Thoracic Surgery
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto
TEL 0757514975
Homepage URL
Email fengshic@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kyoto University Grant
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
Address
Tel
Email

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
2018 Year 01 Month 17 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 Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Seventy-six patients were screened; among them, 48 fulfilled the inclusion criteria.
The final analysis target was 40.
Median observational period was 497 (range 97-1015) days; median survival time was 550 (95% CI 414-686) days.
Mortality rate was 38.7/100 person-years.

Management information
Registered date
2018 Year 01 Month 17 Day
Last modified on
2018 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035216

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.