Nutritional IntoleranceNUTRIGUS 2NCT05146908
Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.
An observational study of Nutritional Intolerance, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In intensive care, gastrointestinal dysfunction may occur in response to systemic insult. Acute gastrointestinal dysfunction (AGID) has been clinically defined by consensus and several grades of severity have been defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Intolerance
- What is being tested?
- 2 Blood samples from arterial and/or central venous catheters, Echography and Data collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2021to 28 Apr 2023
- Phase
- Observational
- 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
Study population: Patients admitted to the ICU for whom enteral nutrition is planned
Who may be able to join
- Next-of-kin/health care proxy has not objected to the inclusion of the patient
- Patient admitted to intensive care
- Predicted duration of MV > 48 hours
- Predicted start of enteral nutrition
- Time to the initiation of enteral nutrition and orotracheal intubation < 36 hours
Who cannot join
- Person subject to a measure of legal protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding women
- Minors
- Non echogenic patient or without an exploitable echographic window
- History of gastric or esophageal surgery
- Limitations of care
Trial locations and contacts
1 site in 1 country.
About this study
In intensive care, gastrointestinal dysfunction may occur in response to systemic insult. Acute gastrointestinal dysfunction (AGID) has been clinically defined by consensus and several grades of severity have been defined. Biomarkers of digestive distress have also been described in intensive care and can be measured directly in the plasma (lipopolysaccharide, intestinal fatty acid binding protein, citrulline, glucagon-like peptide-1).
Enteral nutrition is a frequent therapy in intensive care patients, and its administration is recommended. In general, nurtition is resumed early via a nasogastric tube in patients placed on mechanical ventilation. The resumption of nutrition can be seen as a "challenge" to the gastrointestinal tract, and may thus unmask underlying gastrointestinal dysfunction. Intolerance of enteral nutrition is a symptom of gastrointestinal dysfunction and is associated with poor clinical outcomes. Indeed, it is both a marker of severity by reflecting organ dysfunction and responsible for a reduction in caloric intake that can influence prognosis.
Read more
There is no consensus on the definition of intolerance to enteral nutrition. In practice, it is most often recognized because of regurgitation or vomiting, requiring reduction or discontinuation. In a recent review, the authors emphasize the need for digestive monitoring for early diagnosis of nutritional intolerance.
Gastric echography is a minimally invasive and reliable means of monitoring the gastric contents. In particular, the surface of the antrum has been validated as a way to diagnose a full stomach in intensive care. The measurement of echographic variations in gastric residue with the resumption of enteral nutrition could thus allow the early diagnosis of gastrointestinal dysfunction and food intolerance by preceding vomiting.
Our objective is to show the interest of echographic monitoring of the stomach during the resumption of enteral feeding for the diagnosis of nutritional intolerance. As nutritional intolerance is a symptom of gastrointestinal dysfunction, we will also study this phenomenon by measuring the associations between echographic data, clinical data and biomarkers of gastrointestinal dysfunction.
- Conditions
- Nutritional Intolerance
- Being tested
- 2 Blood samples from arterial and/or central venous catheters, Echography, Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 Blood samples from arterial and/or central venous cathetersBiological
5 mL blood sample taken at the same time as a blood sample scheduled in regular patient management before the introduction of enteral nutrition and 24H after
EchographyOther
In 3 steps:
- before initiation of enteral nutrition
- 4h after initiation of enteral nutrition
- After 24 hours of enteral nutrition
Data collectionOther
At inclusion:
Calculation of severity scores; collection of reason for admission and demographic data; main comorbidities and treatments administered; the time between admission and nutritional recovery; risk factors for gastroparesis; current organ failure and supplements. Presence of parenteral nutrition, ongoing carbohydrate intake. Caloric objective.
Within the first 24 hours, collection of:
- echographic parameters at H0, H4 and H24
- venous congestion parameters
- biological parameters within 24 hours Constitution of a biobank (at H0 and H24)
Within the first 7 days, collection of:
- the occurrence or not of the primary endpoint (and time to occurrence).
- symptoms of gastrointestinal dysfunction
Within 30 days, collection of:
- organ failure and replacement over the period, and mortality.
- the occurrence or not of ventilator-associated lung disease (VAPD). Each patient is followed for 30 days. Survival will be assessed at 30 days before discharge from the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients in intensive care | Ventilated intubated patients for whom enteral nutrition is planned Receives: Biological: 2 Blood samples from arterial and/or central venous catheters; Other: Echography; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric antral surface in mm2
Echographic measurement of the gastric antral area
Measured: Up to 24 hours of enteral nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start29 Nov 2021
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional IntoleranceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146908
- Sponsor's protocol ID
- NGUYEN 2021-2
- Acronym
- NUTRIGUS 2
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berthoud V, Nguyen M, Vinay J, Perrot J, Pages PB, Guinot PG, Bouhemad B. Increase in Diaphragm and Expiratory respiratory muscles thickness is not associated with postoperative pulmonary complications after thoracic surgery: A prospective ultrasound cohort study. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101683. doi: 10.1016/j.accpm.2025.101683. Epub 2025 Nov 12.
PubMed 41238178
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.
- ClinicalTrials.gov ID
- NCT05146908
- Acronym / sponsor ID
- NUTRIGUS 2 / NGUYEN 2021-2
- Conditions
- Nutritional Intolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 7 Dec 2021 (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 intensive care, gastrointestinal dysfunction may occur in response to systemic insult. Acute gastrointestinal dysfunction (AGID) has been clinically defined by consensus and several grades of severity have been defined. Biomarkers of digestive distress have also been described in intensive care and can be measured directly in the plasma (lipopolysaccharide, intestinal fatty acid binding protein, citrulline, glucagon-like peptide-1).
Enteral nutrition is a frequent therapy in intensive care patients, and its administration is recommended. In general, nurtition is resumed early via a nasogastric tube in patients placed on mechanical ventilation. The resumption of nutrition can be seen as a "challenge" to the gastrointestinal tract, and may thus unmask underlying gastrointestinal dysfunction. Intolerance of enteral nutrition is a symptom of gastrointestinal dysfunction and is associated with poor clinical outcomes. Indeed, it is both a marker of severity by reflecting organ dysfunction and responsible for a reduction in caloric intake that can influence prognosis.
There is no consensus on the definition of intolerance to enteral nutrition. In practice, it is most often recognized because of regurgitation or vomiting, requiring reduction or discontinuation. In a recent review, the authors emphasize the need for digestive monitoring for early diagnosis of nutritional intolerance.
Gastric echography is a minimally invasive and reliable means of monitoring the gastric contents. In particular, the surface of the antrum has been validated as a way to diagnose a full stomach in intensive care. The measurement of echographic variations in gastric residue with the resumption of enteral nutrition could thus allow the early diagnosis of gastrointestinal dysfunction and food intolerance by preceding vomiting.
Our objective is to show the interest of echographic monitoring of the stomach during the resumption of enteral feeding for the diagnosis of nutritional intolerance. As nutritional intolerance is a symptom of gastrointestinal dysfunction, we will also study this phenomenon by measuring the associations between echographic data, clinical data and biomarkers of gastrointestinal dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in intensive care | – | Biological: 2 Blood samples from arterial and/or central venous catheters, Other: Echography, Other: Data collectionVentilated intubated patients for whom enteral nutrition is planned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU for whom enteral nutrition is planned
Key inclusion criteria (5 listed)
- Next-of-kin/health care proxy has not objected to the inclusion of the patient
- Patient admitted to intensive care
- Predicted duration of MV > 48 hours
- Predicted start of enteral nutrition
- Time to the initiation of enteral nutrition and orotracheal intubation < 36 hours
Key exclusion criteria (6 listed)
- Person subject to a measure of legal protection (curatorship, guardianship)
- Pregnant, parturient or breastfeeding women
- Minors
- Non echogenic patient or without an exploitable echographic window
- History of gastric or esophageal surgery
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 |
|---|---|---|
| 2 Blood samples from arterial and/or central venous catheters5 mL blood sample taken at the same time as a blood sample scheduled in regular patient management before the introduction of enteral nutrition and 24H after | Biological | Patients in intensive care |
| EchographyIn 3 steps: * before initiation of enteral nutrition * 4h after initiation of enteral nutrition * After 24 hours of enteral nutrition | Other | Patients in intensive care |
| Data collectionAt inclusion: Calculation of severity scores; collection of reason for admission and demographic data; main comorbidities and treatments administered; the time between admission and nutritional recovery; risk factors for gastroparesis; current organ failure and supplements. Presence of parenteral nutrition, ongoing carbohydrate intake. Caloric objective. Within the first 24 hours, collection of: * echographic parameters at H0, H4 and H24 * venous congestion parameters * biological parameters within 24 hours Constitution of a biobank (at H0 and H24) Within the first 7 days, collection of: * the occurrence or not of the primary endpoint (and time to occurrence). * symptoms of gastrointestinal dysfunction Within 30 days, collection of: * organ failure and replacement over the period, and mortality. * the occurrence or not of ventilator-associated lung disease (VAPD). Each patient is followed for 30 days. Survival will be assessed at 30 days before discharge from the study. | Other | Patients in intensive care |
Primary outcome
Gastric antral surface in mm2
Time frame: Up to 24 hours of enteral nutrition
Echographic measurement of the gastric antral area
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 2 Oct 2023.
- Derived from this study: PubMed 41238178Berthoud V, Nguyen M, Vinay J, Perrot J, Pages PB, Guinot PG, Bouhemad B. Increase in Diaphragm and Expiratory respiratory muscles thickness is not associated with postoperative pulmonary complications after thoracic surgery: A prospective ultrasound cohort study. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101683. doi: 10.1016/j.accpm.2025.101683. Epub 2025 Nov 12.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nutritional Intolerance, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 6 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 2 Oct 2023. 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 France. 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?
Gastric antral surface in mm2 (time frame: Up to 24 hours of enteral nutrition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05146908, which also lists 1 linked publication.
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 2 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.