UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045448 |
|---|---|
| Receipt number | R000051879 |
| Scientific Title | A multicenter external validation of individualized infusion rates of intravenous lipid emulsion |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2023/03/06 17:26:11 |
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Basic information
Public title
A multicenter external validation of individualized infusion rates of intravenous lipid emulsion
Acronym
External validation of individualized infusion rates of intravenous lipid emulsion
Scientific Title
A multicenter external validation of individualized infusion rates of intravenous lipid emulsion
Scientific Title:Acronym
External validation of individualized infusion rates of intravenous lipid emulsion
Region
| Japan |
Condition
Condition
Inpatients who initially receives intravenous lipid emulsion
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the individualized infusion rates of intravenous lipid emulsion with external data, based on the developed population triglyceride kinetic model
Basic objectives2
Others
Basic objectives -Others
To assess the efficacy and safety of the individualized infusion rates
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infusion times required and the maximum triglyceride concentrations during the infusion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using triglyceride concentration just before the infusion and body weight, the maximum acceptable infusion rate for each patient is calculated from the developed population triglyceride kinetic model and infused.
* Interventions are performed only at the infusion rate at the initial use, not at the dosage of fat.
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
Patients who are judged to need intravenous lipid emulsion and obtained written informed consent
Key exclusion criteria
Patients younger than 18 years, those with baseline triglyceride concentrations exceeding 300 mg/dL, and those with incomplete data
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Fukushima |
Organization
Kobe Gakuin University
Division name
Faculty of Pharmaceutical Sciences
Zip code
650-8586
Address
1-1-3 Minatojima, Chuo district, Kobe city, Hyogo prefecture, Japan
TEL
078-974-4441
keizo@pharm.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Keizo |
| Middle name | |
| Last name | Fukushima |
Organization
Kobe Gakuin University
Division name
Faculty of Pharmaceutical Sciences
Zip code
650-8586
Address
1-1-3 Minatojima, Chuo district, Kobe city, Hyogo prefecture, Japan
TEL
078-974-4441
Homepage URL
keizo@pharm.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobe Gakuin University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ageo Central General Hospital
Joetsu GeneralHospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ageo Central General Hospital
Address
1-10-10 Kashiwaza, Ageo city, Saitama prefecture, Japan
Tel
048-773-1111
N/A
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
上尾中央総合病院（埼玉）、上越総合病院（新潟）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 10 | 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
| 2021 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 31 | Day |
Other
Other related information
Enrollment of all targeted cases (n=100) was completed by the end of the follow-up data (2022.10.31).
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051879
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
