UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059676 |
|---|---|
| Receipt number | R000068158 |
| Scientific Title | Impact of the Revised Nutrition Protocol on Gastrointestinal Adverse Events and Nutritional Adequacy in Intensive Care Unit Patients: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 12:09:06 |
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Basic information
Public title
A Retrospective Study on the Implementation and Outcomes of the Revised Nutrition Protocol in Intensive Care Unit Patients
Acronym
ICU Nutrition Protocol Revision Study
Scientific Title
Impact of the Revised Nutrition Protocol on Gastrointestinal Adverse Events and Nutritional Adequacy in Intensive Care Unit Patients: A Retrospective Observational Study
Scientific Title:Acronym
Effect of ICU Nutrition Protocol Revision
Region
| Japan |
Condition
Condition
Adult patients(over 18 years old) admitted to the intensive care unit (ICU)
Classification by specialty
| Medicine in general | Surgery in general | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the incidence and characteristics of gastrointestinal adverse events under the implementation of a standardized nutrition protocol in critically ill patients. Specifically we will evaluate the incidence and temporal trends of gastrointestinal symptoms such as constipation diarrhea and vomiting during enteral nutrition and assess their association with the amount of nutritional intake. As secondary analyses we will calculate each patients nutritional adequacy rate (the ratio of administered to required energy and protein intake) and assess the protocol achievement level in our ICU. These findings will help identify current challenges and guide improvements in enteral nutrition procedures and preventive measures for gastrointestinal complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data extracted from medical records will include
Patient characteristics age sex height weight (BMI) admission diagnosis and main ICU condition (e.g. trauma sepsis postoperative management).
Severity indicators: APACHE II and SOFA scores at ICU admission.
Clinical course: ICU admission/discharge dates, duration of mechanical ventilation, types and duration of sedatives, anesthetics, and opioids (as potential factors affecting gut motility).
Nutrition management: day of enteral nutrition initiation (days from ICU admission) route of administration (nasogastric nasojejunal etc.) type of formula (product name fiber content) and use of parenteral nutrition.
Nutritional intake: daily enteral feeding rate volume (mL/day) caloric intake (kcal/day) and protein intake (g/day) including interruptions and reasons.
Gastrointestinal symptoms: daily bowel movements stool consistency (including Bristol scale scores) vomiting events (frequency and content) and gastric residual volume.
Calculated variables:
Required energy/protein: estimated using institutional protocols or established formulas.
Cumulative intake: total energy and protein administered via enteral and parenteral routes.
Nutritional adequacy rate: percentage of actual intake vs. requirement evaluated for the first 7 days and overall ICU stay.
Time to first defecation: days from ICU admission to first bowel movement (constipation defined as >3 days without defecation).
Days with diarrhea: frequency and duration of diarrhea episodes.
Time to onset of GI symptoms: interval between enteral nutrition initiation and occurrence of vomiting or abdominal distension.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food | Other |
Interventions/Control_1
Intervention period:
January 1 2022 December 31 2023 (Old nutrition protocol group approximately 200 patients)
January 1 2024 December 31 2025 (New nutrition protocol group approximately 100 patients)
Patients are managed according to institutional enteral nutrition protocols. The new protocol includes earlier initiation stepwise dose escalation and use of fiber-containing formulas when tolerated.
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
Diagnosis: all eligible ICU cases
Disease stage: all stages included
Age over 18 years at enrollment
All sexes included
Patients admitted to the ICU during the study period
Key exclusion criteria
Patients deemed unsuitable for the nutrition protocol by the attending physician
Patients with DNAR orders or those receiving palliative treatment
Patients under 18 years of age
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | kaori |
| Middle name | |
| Last name | kajitani |
Organization
Tohoku University Hospital
Division name
ICU
Zip code
9808574
Address
1-1 seiryomachi aobaku senndai miyagi japan
TEL
0227177691
kaori.kajitani.b8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | masaki |
| Middle name | |
| Last name | abe |
Organization
Tohoku University Hospital
Division name
ICU
Zip code
9808574
Address
1-1 seiryomachi aobaku senndai miyagi japan
TEL
0227177691
Homepage URL
masaki.abe.e1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Tohoku University Hospital ICU
Address
1-1 seiryomachi aobaku senndai miyagi japan
Tel
0227177691
masaki.abe.e1@tohoku.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 | 11 | Month | 07 | 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
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068158
