Critical IllnessNCT05379582
The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography
A study testing Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound in people with Critical Illness and Acute Gastrointestinal Injury, run by Chinese Medical Association at 1 site in China.
Trial summary
In critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition（EN）. Acute gastrointestinal injury(AGI) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Gastrointestinal Injury
- What is being tested?
- Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- The age is not less than 18 years
- within 24 hours after entering ICU
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 8
- the estimated length of stay in ICU is more than 3 days
- informed consent
Who cannot join
- The normal anatomy of stomach, small intestine or the right colon was significantly changed (Gastrectomy, esophagectomy, pancreaticoduodenectomy, gastrointestinal bypass surgery, the presence of short bowel syndrome,etc.)
- Uncontrolled gastrointestinal bleeding
- Uncontrolled intestinal obstruction
- Uncontrolled mesenteric vascular disease
- Pregnancy
- breastfeeding
Show all 9Show fewer
- Received enteral nutrition or parenteral nutrition within 24 hours prior to ICU admission
- Predict death within 48 hours after ICU admission
- Enrolled in this study before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography in Critically Ill Patients
In critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition（EN）. Acute gastrointestinal injury(AGI) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. In our previously study, we found that transabdominal intestinal sonography is helpful to diagnosis AGI. Thus in this study ,we apply transabdominal gastrointestinal sonography to feeding protocol, to assess the feasibility of gastrointestinal sonography assisted enteral nutrition and its impact on critical ill patients.
Read the detailed description
Patients meeting inclusion and exclusion criteria were randomly assigned to the intervention group and control group. During the first week of initiation of nutrition, enteral nutrition was conducted according to different procedures to observe the impact of different feeding procedures on clinical indicators
- Conditions
- Critical Illness, Acute Gastrointestinal Injury
- Being tested
- Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasoundOther
Once the critical ill patients is stable, enteral nutrition was initiated following a procedure assisted by gastrointestinal ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Implement nutrition therapy according to existing feeding procedures |
| intervention group | Experimental | Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound Receives: Other: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target-reaching rate through enteral route
percentage of participants who reach target calorie through enteral route
Measured: Within first week
Secondary outcomes (13)
The incidence of feeding intolerance
Measured: Within first week
The application of parenteral nutrition
Measured: Within first week
The application of prokinetic drugs
Measured: Within first week
The ues of vasoactive drugs
Measured: Within first week
Mechanical ventilation
Measured: Within first week
Continuous renal replacement
Measured: Within first week
The CRP level
Measured: Day0/1/3/5/7
Mortality
Measured: Day28、Day60、during hospitalization
ICU length of stay
Measured: During ICU stay
Length of hospital stay
Measured: During hospital stay
Platelet count
Measured: Day0,1,3,5,7
Total bilirubin
Measured: Day0,1,3,5,7
Serum creatinine
Measured: Day0,1,3,5,7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jul 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- WenKui Yu, Professor, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379582
- Sponsor's protocol ID
- 2022-050-02
- Status last verified
- Jan 2026
- First submitted
- 28 Apr 2022
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05379582
- Acronym / sponsor ID
- 2022-050-02
- Conditions
- Critical Illness, Acute Gastrointestinal Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 May 2022 (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.
In critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition（EN）. Acute gastrointestinal injury(AGI) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. In our previously study, we found that transabdominal intestinal sonography is helpful to diagnosis AGI. Thus in this study ,we apply transabdominal gastrointestinal sonography to feeding protocol, to assess the feasibility of gastrointestinal sonography assisted enteral nutrition and its impact on critical ill patients.
Detailed description
Patients meeting inclusion and exclusion criteria were randomly assigned to the intervention group and control group. During the first week of initiation of nutrition, enteral nutrition was conducted according to different procedures to observe the impact of different feeding procedures on clinical indicators
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Implement nutrition therapy according to existing feeding procedures |
| intervention group | Experimental | Other: Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasoundImplement nutrition therapy according a procedure assisted by gastrointestinal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age is not less than 18 years
- within 24 hours after entering ICU
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 8
- the estimated length of stay in ICU is more than 3 days
- informed consent
Key exclusion criteria (9 listed)
- The normal anatomy of stomach, small intestine or the right colon was significantly changed (Gastrectomy, esophagectomy, pancreaticoduodenectomy, gastrointestinal bypass surgery, the presence of short bowel syndrome,etc.)
- Uncontrolled gastrointestinal bleeding
- Uncontrolled intestinal obstruction
- Uncontrolled mesenteric vascular disease
- Pregnancy
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 |
|---|---|---|
| Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasoundOnce the critical ill patients is stable, enteral nutrition was initiated following a procedure assisted by gastrointestinal ultrasound. | Other | intervention group |
Primary outcome
Target-reaching rate through enteral route
Time frame: Within first week
percentage of participants who reach target calorie through enteral route
13 secondary outcomes
The incidence of feeding intolerance
Time frame: Within first week
The application of parenteral nutrition
Time frame: Within first week
The application of prokinetic drugs
Time frame: Within first week
The ues of vasoactive drugs
Time frame: Within first week
Mechanical ventilation
Time frame: Within first week
Continuous renal replacement
Time frame: Within first week
The CRP level
Time frame: Day0/1/3/5/7
Mortality
Time frame: Day28、Day60、during hospitalization
ICU length of stay
Time frame: During ICU stay
Length of hospital stay
Time frame: During hospital stay
Platelet count
Time frame: Day0,1,3,5,7
Total bilirubin
Time frame: Day0,1,3,5,7
Serum creatinine
Time frame: Day0,1,3,5,7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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. This study is not recruiting at the moment.
WenKui Yu, Professor principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound in people with Critical Illness and Acute Gastrointestinal Injury, run by Chinese Medical Association 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 28 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target-reaching rate through enteral route (time frame: Within first week). 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 28 Jan 2026.