UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060435 |
|---|---|
| Receipt number | R000068319 |
| Scientific Title | Effect of Post-Pyloric Enteral Nutrition on Gastric Residual Volume in ICU patients: a retrospective study |
| Date of disclosure of the study information | 2026/01/23 |
| Last modified on | 2026/01/22 09:53:29 |
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Basic information
Public title
Effect of Post-Pyloric Enteral Nutrition on Gastric Residual Volume in ICU
Acronym
Effect of Post-Pyloric Enteral Nutrition on Gastric Residual Volume in ICU
Scientific Title
Effect of Post-Pyloric Enteral Nutrition on Gastric Residual Volume in ICU patients: a retrospective study
Scientific Title:Acronym
Effect of Post-Pyloric Enteral Nutrition on Gastric Residual Volume in ICU
Region
| Japan |
Condition
Condition
Patients who underwent enteral feeding via the stomach in the ICU, subsequently switched to post-pyloric feeding, and received each method for at least 24 hours
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Effect of Post-Pyloric feeding on Gastric Residual Volume in Intensive Care Patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GRV on the day before and the day after switching from gastric feeding to post-pyloric feeding
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent post-pyloric feeding after gastric feeding (including gastrostomy) in the ICU, with each procedure maintained for at least 24 hours
2) Patients who stayed in the ICU for at least 72 hours
Key exclusion criteria
1) Patients admitted to the ICU multiple times (second admission and beyond)
2) Patients with a history of upper gastrointestinal surgery
3) Patients admitted due to diseases involving gastrointestinal obstruction or following radical or palliative surgery for such diseases
4) Patients for whom GRV measurement is not performed
5) Patients deemed inappropriate by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama city university hospital
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
2360004
Address
3-9, Fukuura Kanazawa-ku, Yokohama, Japan
TEL
+81457872800
yokose_p12@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
2360004
Address
3-9, Fukuura Kanazawa-ku, Yokohama, Japan
TEL
+81457872800
Homepage URL
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
+81457872800
rinri@yokohama-cu.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
| 2026 | 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
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data: Retrospectively collect data from electronic medical records
1) Age, sex, height, weight, past history, SOFA score, modified CONUT
2) Gastric residual volume, Appearance and color of gastric juice
3) vasopressor, sedative, opioid, prokinetic agents, antacids
4) Enteral nutrition formula dosage, type of enteral nutrition formula, administration rate
5) Labo data
6) Confirm the tip position of the enteral feeding tube, the tip position of the gastric tube for drainage
7) Days until enteral nutrition initiation, presence of enteral nutrition interruption, duration of enteral nutrition during ICU admission
8) Outcomes: In-hospital death, ICU death, hospital length of stay, ICU length of stay, mechanical ventilation duration
Analysis of Primary Endpoints
Paired t-tests or Wilcoxon signed-rank test
Generalized Estimating Equations, Variable Selection via LASSO Estimation; Age, gender, BMI, and enteral nutrition route are forced entry inito final analysis.
Explanatory variables: (1) Age, (2) Gender, (3) BMI, (4) SOFA score, (5) Use of pressor agents, (6) Prokinetic agents, (7) Presence of inflammation (elevated white blood cells and CRP), (8) Enteral nutrition dosage, (9) Enteral nutrition route (gastric or post-pyloric)
Handling of missing values: If a significant number of missing values are identified after data collection, consider conducting a sensitivity analysis.
Management information
Registered date
| 2026 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068319
