Citrullinemia for the Prediction of Enteral Nutrition Tolerance Among Critically Ill Patients

NCT03967795 | Completed DMC

• 1 other identifier: API/2018/93
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The French intensive care societies (SRLF and SFAR), in agreement with the European and American societies for enteral and parenteral nutrition, recommend to quickly administer an artificial nutrition to patients admitted to ICU and for which it is expected that they will not be able to eat normally in the three days of admission. Enteral nutrition should be used in priority if the gut is functioning. However, intolerance to enteral nutrition, such as vomiting, regurgitation, increased residual gastric volume, or diarrhea, occurs in 40% of patients hospitalized in ICU receiving enteral nutrition. Intolerance to enteral nutrition leads to the risk of not receiving enough nutrition. Feeding intolerance also exposes to the risk of acute mesenteric ischemia, especially in the most severe patients under catecholamine for shock. Currently, it is not possible to predict intolerance to enteral nutrition in ICU patients. Thus, the diagnosis of intolerance is made a posteriori while enteral nutrition is in progress. Citrullinemia (normal concentration of 20 to 60 μmol / L), could be a good biomarker of the function of enterocytes involved in the absorption of food. The aim of this study is to evaluate the interest of citrullinemia to predict tolerance to enteral nutrition in ICU patients.

Conditions

Enteral Nutrition; Intensive Care Unit; Biomarkers

Keywords

ICU; enteral nutrition; tolerance; prediction

Outcome Measures

Primary Outcomes (1)

• Feeding intolerance at day-3 and citrulline generation test

  Feeding intolerance evaluated at day-3 of enteral nutrition Citrulline generation test: variation of citrullinemia/90 minutes

  Day 3

Secondary Outcomes (3)

• Feeding intolerance at dat 3 and basal plasma citrulline

  Day 3

• Citrullinemia and cumulative amount of enteral nutrition

  Day 3

• Citrullinemia and enteral nutrition complications occurrence

  First week

Study Arms (1)

All patients

OTHER

Citrulline genration test before starting enteral nutrition At ICU admission, a blood sample is collected (i) before and (ii) 90 minutes after N2-L-Alanyl-L-Glutamine administration

Drug: N2-L-Alanyl-L-Glutamine (Substance)

Interventions

N2-L-Alanyl-L-Glutamine (Substance) DRUG

20 gr of 10% N2-L-Alanyl-L-Glutamine, dilution in 200 ml of water for injection, intravenous perfusion over 30 minutes

Also known as: Dipeptiven

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• patient admited to ICU
• expected hospital stay of at least 3 days
• indication of enteral nutrition.
• presence of an arterial catheter
• signed informed consent

You may not qualify if:

• contraindication to enteral nutrition (e.g. non-functional digestive tract, mesenteric ischemia, occlusion, digestive fistula, active gastrointestinal bleeding)
• pregnancy ;
• chronic renal failure;
• chronic intestinal pathology

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Chu de Besancon

Besançon, 25030, France

Location

MeSH Terms

Interventions

alanylglutamine

Study Officials

• Gaël PITON, MD

  CHU DE BESANCON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A bolus of Dipeptiven (Glutamine-Alanine) administered intravenously over 30 minute (20 gramme of N2-L-Alanyl-L-Glutamine solution, dilution in 200 ml of water for injection, intravenous perfusion over 30 minutes).

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: November 28, 2019
• Primary Completion: March 27, 2023
• Study Completion: April 24, 2023
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

FR (1)