UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038054 |
|---|---|
| Receipt number | 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 21:25:03 |
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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
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
kamoshitas@otsuka.jp
Sponsor or person
Institute
Jichi Medical University, Data science center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043365
