UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054236 |
|---|---|
| Receipt number | R000061929 |
| Scientific Title | Clinical implementation of the infusion rate individualization of soybean oil-based intravenous lipid emulsion: A multi-center descriptive cohort study |
| Date of disclosure of the study information | 2024/04/24 |
| Last modified on | 2024/04/23 16:25:32 |
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Basic information
Public title
Clinical implementation of the infusion rate individualization of intravenous lipid emulsion
Acronym
Clinical implementation of the infusion rate individualization of intravenous lipid emulsion
Scientific Title
Clinical implementation of the infusion rate individualization of soybean oil-based intravenous lipid emulsion: A multi-center descriptive cohort study
Scientific Title:Acronym
Clinical implementation of the infusion rate individualization of intravenous lipid emulsion
Region
| Japan |
Condition
Condition
Patients who clinically need intravenous lipid emulsion
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition therapy, serving as a source of nonprotein calories and essential fatty acids. Although parenteral nutrition guidelines recommend that ILE should be incorporated in parenteral nutrition, the infusion rate of ILE limits its clinical use. The infusion rate exceeding the lipid metabolism capacity can cause adverse events such as fat overload syndrome and acute respiratory distress syndrome. The lowest possible infusion rate is necessary to avoid these adverse events, but it requires a longer infusion time, which may reduce patients' quality of life and potentially increase the infection risk. This trade-off issue may be overcome by establishing a safe and efficient infusion rate. We previously reported the feasibility of individualizing of ILE infusion rate according to patient body weight and baseline TG concentration. In this clinical trial, our objective is to evaluate the tolerability and accuracy of individualizing of ILE infusion rate in a clinical setting and implement it into clinical practice.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum triglyceride concentration on the final day of administration
Key secondary outcomes
Laboratory parameters, including liver function, renal function, and markers of inflammation
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
Baseline triglyceride level < 300 mg/dL
Key exclusion criteria
Patients with estimated individualized infusion rates less than 10 mL/h or greater than 0.33 g/kg/h
Target sample size
120
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, Saitama 362-8588 Japan
Tel
048-773-1298
acgh-ct@ach.or.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
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
| 2024 | Year | 04 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Calculate the maximum acceptable infusion rate (MaxInfRate), defined as the infusion rate at which the maximum triglyceride concentration (TGmax) does not exceed 400 mg/dL with a 90% probability, for each individual patient. Administer ILE daily using MaxInfRate (for <7 days) and verify whether the TGmax on the final day meets the defined criteria.
Management information
Registered date
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061929
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