- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05146908
Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance. (NUTRIGUS 2)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Dijon, France, 21000
- Chu Dijon Bourogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients in intensive care
Ventilated intubated patients for whom enteral nutrition is planned
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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
In 3 steps:
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:
Within the first 7 days, collection of:
Within 30 days, collection of:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric antral surface in mm2
Time Frame: Up to 24 hours of enteral nutrition
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Echographic measurement of the gastric antral area
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Up to 24 hours of enteral nutrition
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NGUYEN 2021-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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