UMIN-CTR Clinical Trial

Basic information
Public title	Survey of nutritional management and investigation of the relationship between amount of nutrition and outcomes for total parenteral nutrition patients : A cohort study using the medical database
Acronym	Survey of nutritional management and outcomes for total parenteral nutrition patients
Scientific Title	Survey of nutritional management and investigation of the relationship between amount of nutrition and outcomes for total parenteral nutrition patients : A cohort study using the medical database
Scientific Title:Acronym	Survey of nutritional management and outcomes for total parenteral nutrition patients
Region	Japan

Condition
Condition	Patients who were managed by total parenteral nutrition
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the total parenteral nutrition management in acute hospital and to investigate the relationship between amount of nutrition and outcomes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Hospital mortality
Key secondary outcomes	(1)Activity of daily living (2)Re-admission rate (3)Length of hospital stay

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)Patients who were inserted central venous catheter from January 1, 2009 to December 31, 2018 (2)Patients aged 18 years or older
Key exclusion criteria	(1)Patients whose body weight data is missing (2)Patients whose body weight is less than 10 kg (3)Patients who were discharged within 10 days after central venous catheter insertion (4)Patients who received oral feeding or tube feeding within 10 days after central venous catheter insertion (5)Patients whose dose of parenteral nutrition was less than 5 kcal/kg/day or more than 60 kcal/kg/day on average from 4 to10 days (during 7 days) after central venous catheter insertion (6)Patients whose dose of parenteral amino acids were less than 0.1 g/kg/day or more than 3 g/kg/day on average from 4 to10 days (during 7 days) after central venous catheter insertion (7)Patients whose dose of parenteral lipids were more than 3 g/kg/day on average from 4 to10 days (during 7 days) after central venous catheter insertion
Target sample size	50000

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Sasabuchi
Organization	Jichi Medical University
Division name	Data science center
Zip code	329-0431
Address	3311-1 Yakushiji, Shimono Tochigi
TEL	0285-44-2111
Email	sasabuchi@jichi.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Kamoshita
Organization	Otsuka Pharmaceutical Factory, Inc.
Division name	Applied Clinical Development Department
Zip code	101-0048
Address	2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL	03-5217-5954
Homepage URL
Email	kamoshitas@otsuka.jp

Sponsor
Institute	Jichi Medical University, Data science center
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc. Applied Clinical Development Department
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Otsuka Pharmaceutical Factory, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Ethics Committee, Jichi Medical University
Address	3311-1 Yakushiji, Shimono Tochigi
Tel	0285-58-8933
Email	rinri@jichi.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	自治医科大学データサイエンスセンター（栃木県） Data science center, Jichi Medical University

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 15 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	2019 Year 10 Month 01 Day
Date of IRB	2019 Year 11 Month 07 Day
Anticipated trial start date	2019 Year 11 Month 07 Day
Last follow-up date	2019 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other

Other related information

Study design A cohort study using the medical database Data source A medical database provided by Medical Data Vision Co.Ltd. The database is based on the DPC data/medical and technical service claims data. The database covers about 20% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection. Survey of nutritional management The following items are surveyed in patients who were inserted central venous catheter. Patient characteristics Time of the start of nutritional management Category of catheter and type of parenteral nutrition product Daily amount of parenteral nutrition from 1 to 10 days after central venous catheter insertion Mean of the daily amount of parenteral nutrition Factors that influence parenteral nutrition management Relationship between amount of nutrition and outcomes Patients are divided into 3 groups according to the achievement of nutritional goal. Nutritional goal Energy 20 kcal/kg/day or more Amino acids 1.0 g/kg/day or more Lipids 2.5 g/day or more Study groups (1)Not achieved any of the goal (2)Achieved partial goals (3)Achieved all goals Statistical analysis The hospital mortality, activity of daily living, re-admission rate and length of hospital stay are compared between the 3 study groups (Not achieved any of the goal, Achieved partial goals, and Achieved all goals). Logistic regression analysis is used to calculate odds ratio and 95% confidence interval.

Management information
Registered date	2019 Year 09 Month 19 Day
Last modified on	2020 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043365