Critical IllnessNCT07521111
Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients
An observational study of Critical Illness and Enteral Nutrition Intolerance, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to explore the correlation between gastrointestinal blood flow and the incidence of enteral nutrition intolerance (ENI) and its symptoms in critically ill patients, construct and compare predictive models including blood flow parameters, and evaluate their incremental predictive value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Enteral Nutrition Intolerance, Enteral Nutrition Feeding
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2026to 30 Jun 2027
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients admitted to the Intensive Care Units (ICUs) of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. These patients require continuous enteral nutrition support with an expected duration of more than 7 days.
Who may be able to join
- Age > 18 years old.
- Expected duration of enteral nutrition support > 7 days.
- Patients or their legal representatives sign the informed consent form.
Who cannot join
- History of major gastrointestinal surgery such as subtotal gastrectomy and gastrointestinal anastomosis.
- Contraindications to abdominal point-of-care ultrasound (POCUS) examination (e.g., recent large-area abdominal burns, dressings blocking movement, open abdomen).
- Presence of severe gastrointestinal diseases such as gastroparesis, intestinal obstruction, digestive tract perforation, and gastrointestinal bleeding upon admission.
- Presence of severe peripheral vascular disease or valvular heart disease.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
junjie hua, 86 18175005982, junjie.hua615@gmail.com
About this study
Official title: Study on the Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients
This study aims to explore the correlation between gastrointestinal blood flow and the incidence of enteral nutrition intolerance (ENI) and its symptoms in critically ill patients, construct and compare predictive models including blood flow parameters, and evaluate their incremental predictive value.
Read the detailed description
Enteral nutrition (EN) is the preferred route of nutritional support for critically ill patients. However, the occurrence of enteral nutrition intolerance (ENI) often limits its efficacy and interrupts nutritional supply. Current clinical assessment methods and existing predictive models for ENI mostly rely on subjective or delayed indicators. Normal gastrointestinal function is highly dependent on adequate blood perfusion and unobstructed venous return , but current research pays insufficient attention to the status of gastrointestinal blood flow. Point-of-care ultrasound (POCUS), due to its dynamic and visual nature, can be used to objectively evaluate these gastrointestinal indicators.
This study is designed as a prospective observational cohort study involving Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine. Researchers will perform bedside ultrasound evaluations at four specific time points: upon ICU admission, and on Day 1, Day 4, and Day 7 of enteral nutrition. The ultrasound assessments will measure various hemodynamic parameters including diameter, time-averaged maximum velocity, blood flow, and VExUS scores of major vessels such as the celiac artery (CA), superior mesenteric artery (SMA), inferior vena cava (IVC), hepatic vein (HV), and portal vein (PV).
The ultimate goal of this study is to employ machine learning algorithms to construct and compare three predictive models: a clinical indicator model, a blood flow parameter model, and a combined clinical-blood flow model. By doing so, the study will explore the independent predictive value of gastrointestinal blood flow for ENI and its symptoms in critically ill patients, evaluate the incremental value of adding blood flow parameters to the prediction models, and validate the models using an external dataset.
- Conditions
- Critical Illness, Enteral Nutrition Intolerance, Enteral Nutrition Feeding, Prediction Models, Machine Learning
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Eligible ICU patients from Ruijin Hospital are receiving enteral nutrition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Enteral Nutrition Intolerance
The rate of enteral nutrition intolerance occurs during the first 7 days of enteral nutrition support.
Measured: Assessed daily from Day 1 to Day 7 of enteral nutrition
Secondary outcomes (4)
Incidence of gastrointestinal symptoms
The rate of gastrointestinal symptoms, including reflux, vomiting, aspiration, diarrhea, delayed gastric emptying, and abdominal distension
Measured: Assessed daily from Day 1 to Day 7 of enteral nutrition
Achievement rate of targeted feeding volume
The rate of achieving 80% of the target feeding volume
Measured: Assessed daily from Day 1 to Day 7 of enteral nutrition
Length of ICU stay
Measured: Until ICU discharge, up to 28 days
28-day mortality rate
Measured: up to day 28 post-ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start25 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521111
- Sponsor's protocol ID
- ZWQ-2026-GIBF
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Predictive Value of Gastrointestinal Blood Flow for Enteral Nutrition Intolerance in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07521111
- Acronym / sponsor ID
- ZWQ-2026-GIBF
- Conditions
- Critical Illness, Enteral Nutrition Intolerance, Enteral Nutrition Feeding, Prediction Models, Machine Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the correlation between gastrointestinal blood flow and the incidence of enteral nutrition intolerance (ENI) and its symptoms in critically ill patients, construct and compare predictive models including blood flow parameters, and evaluate their incremental predictive value.
Detailed description
Enteral nutrition (EN) is the preferred route of nutritional support for critically ill patients. However, the occurrence of enteral nutrition intolerance (ENI) often limits its efficacy and interrupts nutritional supply. Current clinical assessment methods and existing predictive models for ENI mostly rely on subjective or delayed indicators. Normal gastrointestinal function is highly dependent on adequate blood perfusion and unobstructed venous return , but current research pays insufficient attention to the status of gastrointestinal blood flow. Point-of-care ultrasound (POCUS), due to its dynamic and visual nature, can be used to objectively evaluate these gastrointestinal indicators.
This study is designed as a prospective observational cohort study involving Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine. Researchers will perform bedside ultrasound evaluations at four specific time points: upon ICU admission, and on Day 1, Day 4, and Day 7 of enteral nutrition. The ultrasound assessments will measure various hemodynamic parameters including diameter, time-averaged maximum velocity, blood flow, and VExUS scores of major vessels such as the celiac artery (CA), superior mesenteric artery (SMA), inferior vena cava (IVC), hepatic vein (HV), and portal vein (PV).
The ultimate goal of this study is to employ machine learning algorithms to construct and compare three predictive models: a clinical indicator model, a blood flow parameter model, and a combined clinical-blood flow model. By doing so, the study will explore the independent predictive value of gastrointestinal blood flow for ENI and its symptoms in critically ill patients, evaluate the incremental value of adding blood flow parameters to the prediction models, and validate the models using an external dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | –Eligible ICU patients from Ruijin Hospital are receiving enteral nutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the Intensive Care Units (ICUs) of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. These patients require continuous enteral nutrition support with an expected duration of more than 7 days.
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Expected duration of enteral nutrition support > 7 days.
- Patients or their legal representatives sign the informed consent form.
Key exclusion criteria (5 listed)
- History of major gastrointestinal surgery such as subtotal gastrectomy and gastrointestinal anastomosis.
- Contraindications to abdominal point-of-care ultrasound (POCUS) examination (e.g., recent large-area abdominal burns, dressings blocking movement, open abdomen).
- Presence of severe gastrointestinal diseases such as gastroparesis, intestinal obstruction, digestive tract perforation, and gastrointestinal bleeding upon admission.
- Presence of severe peripheral vascular disease or valvular heart disease.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Enteral Nutrition Intolerance
Time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition
The rate of enteral nutrition intolerance occurs during the first 7 days of enteral nutrition support.
4 secondary outcomes
Incidence of gastrointestinal symptoms
Time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition
Achievement rate of targeted feeding volume
Time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition
Length of ICU stay
Time frame: Until ICU discharge, up to 28 days
28-day mortality rate
Time frame: up to day 28 post-ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Enteral Nutrition Intolerance, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiqing Zhang, Ph.D (8618521525300, weiq.zh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Enteral Nutrition Intolerance (time frame: Assessed daily from Day 1 to Day 7 of enteral nutrition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.