UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056973 |
|---|---|
| Receipt number | R000063644 |
| Scientific Title | Association between gastric residual volume and clinical outcomes during post-pyloric enteral nutrition |
| Date of disclosure of the study information | 2025/02/08 |
| Last modified on | 2025/02/14 11:47:53 |
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Basic information
Public title
Association between gastric residual volume and clinical outcomes during post-pyloric enteral nutrition
Acronym
Significance of gastric residual volume during post-pyloric enteral nutrition
Scientific Title
Association between gastric residual volume and clinical outcomes during post-pyloric enteral nutrition
Scientific Title:Acronym
Significance of gastric residual volume during post-pyloric enteral nutrition
Region
| Japan |
Condition
Condition
Patients who were admitted to the intensive care unit and received the post-pyloric enteral nutrition
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between an increase in gastric residual volume during post-pyloric enteral nutrition and clinical outcomes
Basic objectives2
Others
Basic objectives -Others
Examination of relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
90-day mortality
Key secondary outcomes
1) ICU length of stay, 2) ICU mortality, 3) 28-day mortality, 4) hospital mortality, 5) ventilator free days, 6) hospital length of stay, 7) Number of days until large GRV occurs, 8) Frequency of large GRV over the duration of the stay, 8) volume of GRV, 9) volume of enteral nutrition, 10) Number of days until the start of post-pyloric nutrition
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 received post-pyloric enteral nutrition for more than 24 hours
2) Patients who stayed in the ICU for at least 72 hours
3) Patients with two or more GRVs measured during post-pyloric enteral nutrition in ICU
Key exclusion criteria
1) Patients who received enteral nutrition via an enterostomy
2) Patients with a history of upper gastrointestinal surgery
3) Patients who were admitted to ICU with diseases that involve digestive tract obstruction, such as intestinal obstruction.
4) Patients for whom gastric residual volume has not been measured
Target sample size
600
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 Medecine
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
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 Medecine
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
+81457872800
Homepage URL
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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, Kanagawa
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
| 2025 | Year | 02 | Month | 08 | 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
| 2024 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 08 | 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
1) Patients characteristics: age, gender, height, weight, past history, comorbidities, nutritional status, diagnosis, SOFA score
2) Symptoms of feeding intolerance: large GRV, vomiting, diarrhea, bleeding, intestinal distention, intestinal peristalsis
3) Enteral nutrition dosage, type of enteral nutrition
4) Vasoconstrictors, sedatives, narcotics, intestinal peristalsis drugs
5) Serum albumin
6) Intra-abdominal pressure
7) Position or diameter of enteral feeding tubes and nasogastric tubes
8) Assisted circulation (ECMO, IABP, IMPELLA, VAD)
9) Enteral nutrition related outcomes
10) Outcomes: 90-day mortality, in-hospital mortality, ICU mortality, length of stay in hospital, length of stay in ICU, duration of ventilation
Statistical analysis
Logistic regression analysis: the association between large GRV (>=250 ml/day) and 90-day mortality
Covariates
(1) GRV (2) age (3) sex (4) BMI (5) SOFA score (6) gastrointestinal disease, (7) internal medicine or surgery, (8) vasopressor, (9) insulin-dependent DM, (10) IAP, (11) narcotics, (12) sedatives, (13) assisted circulation (ECMO, IABP, IMPELLA, VAD)
Secondary analysis of the main analysis
1) Define large GRV as >=500 ml/day.
2) Use gastrointestinal dysfunction instead of GRV.
Handling of missing values: If there are missing values that cannot be ignored, conduct a sensitivity analysis that does not include those covariates.
Comparison between groups(Presence or absence of large GRV): Patient background, nutrition-related outcomes, clinical outcomes
t-test or u-test, Pearson's chi-square test
Evaluation of the association between the use of prokinetic agents and 90-day mortality in patients with GRV >=250 ml/day
Logistic regression analysis
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063644
