NCT05146908

Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Nutritional Intolerance

Interventions

Type	Name	Description
BIOLOGICAL	2 Blood samples from arterial and/or central venous catheters	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
OTHER	Echography	In 3 steps: * before initiation of enteral nutrition * 4h after initiation of enteral nutrition * After 24 hours of enteral nutrition
OTHER	Data collection	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.

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-04-28
• Completion: 2023-04-28
• First posted: 2021-12-07
• Last updated: 2023-10-02

Locations

1 site across 1 country: France