Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.

NCT ID: NCT05146908

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2023-04-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients in intensive care

Ventilated intubated patients for whom enteral nutrition is planned

2 Blood samples from arterial and/or central venous catheters

Intervention Type: BIOLOGICAL

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

Echography

Intervention Type: OTHER

In 3 steps:

• before initiation of enteral nutrition
• 4h after initiation of enteral nutrition
• After 24 hours of enteral nutrition

Data collection

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: BIOLOGICAL

Echography

In 3 steps:

• before initiation of enteral nutrition
• 4h after initiation of enteral nutrition
• After 24 hours of enteral nutrition

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

NGUYEN 2021-2

Identifier Type: -

Identifier Source: org_study_id