UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Nutrition-related factors associated with waiting list mortality in patients with interstitial lung disease
Title of the study (Brief title)	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	Shinichi Harashima
Organization	Kyoto University
Division name	Diabetes, Endocrinology and Nutrition
Address	54 Shogoin Kawahara-cho Sakyo-ku Kyoto
TEL	0757513560
Email	harasima@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Toyofumi F. Chen-Yoshikawa
Organization	Kyoto University
Division name	Thoracic Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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