Intestinal IschemiaNCT07001943
Correlation Study Between SMA Blood Flow Reactivity and Acute Gastrointestinal Injury in Critically Ill Patients
An observational study of Intestinal Ischemia and Critical Illness, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to address the challenges of enteral nutrition support in critically ill ICU patients with varying gastrointestinal function. We'll use bedside Doppler ultrasound to monitor superior mesenteric artery (SMA) blood flow changes post - feeding, exploring its correlation with Acute Gastrointestinal Injury… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Ischemia, Critical Illness, Enteral Nutrition Feeding
- What is being tested?
- enteral nutrition
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jul 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be selected from adult patients admitted to the ICU. Participants will be those aged between 18 and 80 years old, with an expected ICU stay of more than 72 hours after enrolled, and who require the initiation of enteral nutrition support. These patients are at risk of gastrointestinal dysfunction and acute gastrointestinal injury (AGI), making them suitable candidates for a study focused on optimizing enteral nutrition strategies and monitoring gastrointestinal blood flow.
Who may be able to join
- Adults aged ≥18 years and ≤80 years.
- Admitted to the study with a expected stay of more than 72 hours.
- Require initiation of enteral nutrition support.
Who cannot join
- Pre-existing severe gastrointestinal diseases.
- Patients with gastrointestinal bleeding.
- Patients with bowel obstruction.
- Pregnant or lactating women.
- Patients with contraindications to bedside Doppler ultrasound.
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
Peking union medical college hospital
Beijing, Beijing Municipality, 100730
Yuankai Zhou Attending Physician, MD, 00886-10-69152300, zhouyuankai@aliyun.com
About this study
Official title: Correlation Study Between SMA Blood Flow Reactivity and Acute Gastrointestinal Functional Injury in Critically Ill Patients
This study aims to address the challenges of enteral nutrition support in critically ill ICU patients with varying gastrointestinal function. We'll use bedside Doppler ultrasound to monitor superior mesenteric artery (SMA) blood flow changes post - feeding, exploring its correlation with Acute Gastrointestinal Injury (AGI) and other hemodynamic indicators. Our goals are to identify the patterns of SMA blood flow changes, establish a predictive model linking SMA blood flow reactivity to AGI risk, and propose individualized enteral nutrition strategies based on intestinal hemodynamics. Through this innovative approach, we hope to enhance the safety of enteral nutrition, reduce AGI incidence, and improve patient outcomes.
- Conditions
- Intestinal Ischemia, Critical Illness, Enteral Nutrition Feeding, Hemodynamics, Ultrasonography, Doppler
- Being tested
- enteral nutrition
- Keywords
- Enteral Nutrition, Critical Illness, Intestinal Ischemia, Hemodynamics
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionOther
We'll use an enteral nutrition intervention with intact protein formulations. Initiate nasogastric tube feeding at 20ml/h and continue for 24 hours. Adjust feeding strategies based on patients' SMA blood flow reactivity.
What is being measured
The primary outcome is the main question the study is designed to answer.
feeding intolerance
the incidence of feeding intolerance, defined as the frequency of feeding interruptions or reductions due to gastrointestinal complications like vomiting, gastric residuals, or abdominal distension during the study period.
Measured: From enrollment to the end of treatment at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal IschemiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001943
- Sponsor's protocol ID
- SMART(SMA Reactivity Trial)
- Status last verified
- Apr 2025
- First submitted
- 25 May 2025
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study Between SMA Blood Flow Reactivity and Acute Gastrointestinal Functional Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07001943
- Acronym / sponsor ID
- SMART(SMA Reactivity Trial)
- Conditions
- Intestinal Ischemia, Critical Illness, Enteral Nutrition Feeding, Hemodynamics, Ultrasonography, Doppler
- Keywords
- Enteral Nutrition, Critical Illness, Intestinal Ischemia, Hemodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Jun 2025 (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 address the challenges of enteral nutrition support in critically ill ICU patients with varying gastrointestinal function. We'll use bedside Doppler ultrasound to monitor superior mesenteric artery (SMA) blood flow changes post - feeding, exploring its correlation with Acute Gastrointestinal Injury (AGI) and other hemodynamic indicators. Our goals are to identify the patterns of SMA blood flow changes, establish a predictive model linking SMA blood flow reactivity to AGI risk, and propose individualized enteral nutrition strategies based on intestinal hemodynamics. Through this innovative approach, we hope to enhance the safety of enteral nutrition, reduce AGI incidence, and improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from adult patients admitted to the ICU. Participants will be those aged between 18 and 80 years old, with an expected ICU stay of more than 72 hours after enrolled, and who require the initiation of enteral nutrition support. These patients are at risk of gastrointestinal dysfunction and acute gastrointestinal injury (AGI), making them suitable candidates for a study focused on optimizing enteral nutrition strategies and monitoring gastrointestinal blood flow.
Key inclusion criteria (3 listed)
- Adults aged ≥18 years and ≤80 years.
- Admitted to the study with a expected stay of more than 72 hours.
- Require initiation of enteral nutrition support.
Key exclusion criteria (5 listed)
- Pre-existing severe gastrointestinal diseases.
- Patients with gastrointestinal bleeding.
- Patients with bowel obstruction.
- Pregnant or lactating women.
- Patients with contraindications to bedside Doppler ultrasound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutritionWe'll use an enteral nutrition intervention with intact protein formulations. Initiate nasogastric tube feeding at 20ml/h and continue for 24 hours. Adjust feeding strategies based on patients' SMA blood flow reactivity. | Other | – |
Primary outcome
feeding intolerance
Time frame: From enrollment to the end of treatment at 3 days
the incidence of feeding intolerance, defined as the frequency of feeding interruptions or reductions due to gastrointestinal complications like vomiting, gastric residuals, or abdominal distension during the study period.
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 5 Sep 2025.
- 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 Intestinal Ischemia and Critical Illness, run by Peking Union Medical College 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 5 Sep 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feeding intolerance (time frame: From enrollment to the end of treatment at 3 days). 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 5 Sep 2025.