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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038054
Receipt No. R000043365
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
Date of disclosure of the study information 2019/11/15
Last modified on 2020/06/18

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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