UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056795 |
|---|---|
| Receipt number | R000064900 |
| Scientific Title | A survey on the management of parenteral nutrition during fasting in patients with chronic kidney disease and association between the prescribed doses of parenteral nutrition and prognosis: a cohort study using a medical database |
| Date of disclosure of the study information | 2025/01/23 |
| Last modified on | 2025/01/23 15:12:11 |
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Basic information
Public title
A survey on the management of parenteral nutrition during fasting in patients with chronic kidney disease and association between the prescribed doses of parenteral nutrition and prognosis: a cohort study using a medical database
Acronym
Management of parenteral nutrition during fasting and prognosis for patients with chronic kidney disease (CKD)
Scientific Title
A survey on the management of parenteral nutrition during fasting in patients with chronic kidney disease and association between the prescribed doses of parenteral nutrition and prognosis: a cohort study using a medical database
Scientific Title:Acronym
Management of parenteral nutrition during fasting and prognosis for patients with chronic kidney disease (CKD)
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the management of parenteral nutrition during fasting and investigate the association between the prescribed doses of parenteral nutrition and prognosis for patients with CKD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality (mortality during hospitalization)
Key secondary outcomes
(1) All-cause mortality (mortality during hospitalization and rehospitalization)
(2) 30-day mortality (all-cause mortality within 30 days after the 10th day of fasting)
(3) Readmission (readmission within 30 days after discharge)
(4) Activities of daily living
(5) Length of stay
(6) Medical costs
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 with CKD who were hospitalized between January 1, 2012 and December 31, 2023
(2) Patients who were confirmed to have fasted for >= 10 consecutive days
(3) Patients aged >= 18 years upon hospitalization
Key exclusion criteria
None in particular
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Hosojima |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Clinical Nutrition Science, Kidney Research Center
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata
TEL
025-368-9312
hoso9582@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoto |
| Middle name | |
| Last name | Hamamoto |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Medical Affairs Department
Zip code
101-0048
Address
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL
03-5217-5954
Homepage URL
Hamamoto.Ryoto@otsuka.jp
Sponsor or person
Institute
Department of Clinical Nutrition Science, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
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
Ethics Committee of Niigata University
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata, 951-8580, Japan
Tel
025-227-2625
ethics@adm.niigata-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
A cohort study
Data source
A medical database by Medical Data Vision Co. Ltd. The database is based on the DPC data/medical claims database and covers approximately 23% of all DPC hospitals in Japan. All data is anonymized for personal information protection.
(1) Survey of nutritional management
Nutritional management is surveyed based on the prescription and treatment records available in the database. We analyze the following items.
･Trends in parenteral nutrition prescription amounts
･Types of prescribed infusion preparations
･Distribution of parenteral nutrition prescription amounts
(2) Association between the nutritional prescription doses and prognosis
The association between the nutritional prescription doses and prognosis are investigated by multivariable logistic analysis using estimated odds ratios and 95% confidence intervals adjusted for patient backgrounds as confounding factors.
Management information
Registered date
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064900
