UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058165 |
|---|---|
| Receipt number | R000066486 |
| Scientific Title | Comparison of Glycemic Variability Between Nasogastric and Postpyloric Enteral Nutrition in ICU: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/12 21:45:51 |
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Basic information
Public title
Comparison of Glycemic Variability Between Nasogastric and Postpyloric Enteral Nutrition in Critically Ill Patients
Acronym
Comparison of Glycemic Variability Between Nasogastric and Postpyloric Enteral Nutrition in Critically Ill Patients
Scientific Title
Comparison of Glycemic Variability Between Nasogastric and Postpyloric Enteral Nutrition in ICU: A Retrospective Observational Study
Scientific Title:Acronym
Comparison of Glycemic Variability Between Nasogastric and Postpyloric Enteral Nutrition in ICU: A Retrospective Observational Study
Region
| Japan |
Condition
Condition
ICU-admitted critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This retrospective study compares the impact of different enteral feeding routes gastric versus postpyloric on glycemic variability in critically ill patients who received continuous enteral nutrition in the ICU of our hospital
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean blood glucose level (72hour average)
Standard deviation (SD) of blood glucose levels
Coefficient of variation (CV)
Key secondary outcomes
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
Adult patients aged 18 years or older
Patients who received continuous enteral nutrition with Peptamen AF for more than 72 hours after ICU admission
Patients whose blood glucose levels were measured every 4 hours for at least 72 hours
Key exclusion criteria
Patients receiving total parenteral nutrition (TPN)
Patients undergoing treatments that strongly affect blood glucose levels (e.g., severe hepatic failure, diabetic coma, high-dose steroid therapy)
Patients with persistent hypoglycemia due to septic shock
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | yuusuke |
| Middle name | |
| Last name | kusaka |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Intensive Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki-city, Osaka 569-8686, Japan
TEL
072-683-1221
yuusuke.kusaka@ompu.ac.jp
Public contact
Name of contact person
| 1st name | sho |
| Middle name | |
| Last name | tomihata |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Intensive Care Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki-city, Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
sho.tomihata@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University Hospita
Address
2-7 Daigakumachi, Takatsuki-city, Osaka 569-8686, Japan
Tel
072-683-1221
yuusuke.kusaka@ompu.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 | 06 | Month | 12 | 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
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066486
