Enteral NutritionPREDICTNCT03967795
Citrullinemia for the Prediction of Enteral Nutrition Tolerance Among Critically Ill Patients
A study testing N2-L-Alanyl-L-Glutamine (Substance) in people with Enteral Nutrition and Intensive Care Unit, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition, Intensive Care Unit, Biomarkers
- What is being tested?
- N2-L-Alanyl-L-Glutamine (Substance)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2019to 24 Apr 2023
- Phase
- Interventional
- 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
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Citrulline is an amino acid mainly produced by enterocytes from glutamine.
Citrullinemia ≤ 20μmol/L is a biomarker of enterocyte mass reduction, secondary to the reduction of small bowel length or secondary to villous atrophy diseases. A patient with low citrullinemia is probably at risk of enteral nutrition malabsorption.
Citrulline generation test consists of measuring the course of citrullinemia after an oral or intravenous administration of glutamine, the main precursor of citrulline. When the small bowel is functional, administration of glutamine is followed by the elevation of citrullinemia. On the contrary, when there is enterocyte dysfunction or reduction, citrullinemia does not vary after glutamine administration. Peeters et al have shown the feasibility of carrying out the citrulline generation test in patients hospitalized in the ICU. In this context, intravenous administration of glutamine (20 gr of 10% N2-L-Alanyl-L-Glutamine, dilution in 200 ml of water for injection, IV infusion over 30 minutes) followed by monitoring of citrullinemia (basal time and then after 90 minutes, on arterial sampling) is feasible and reproducible.
There is currently no data available on the relationship between citrullinemia measured at ICU admission and tolerance to enteral nutrition in the days following ICU admission. Similarly, the value of the citrulline generation test for evaluating enteral nutrition tolerance is unknown.
The investigators hypothesize that patients with low citrullinemia at ICU admission, as well as those with a decreased citrullinemia elevation after Dipeptiven bolus, will have less tolerance to enteral nutrition than patients with normal citrullinemia.
PREDICT is the first study evaluating the interest of citrullinemia and the citrulline generation test to predict feeding tolerance among critically ill patients.
- Conditions
- Enteral Nutrition, Intensive Care Unit, Biomarkers
- Being tested
- N2-L-Alanyl-L-Glutamine (Substance)
- Keywords
- ICU, enteral nutrition, tolerance, prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N2-L-Alanyl-L-Glutamine (Substance)Drug
Also called Dipeptiven
20 gr of 10% N2-L-Alanyl-L-Glutamine, dilution in 200 ml of water for injection, intravenous perfusion over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: N2-L-Alanyl-L-Glutamine (Substance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 3
Secondary outcomes (3)
Feeding intolerance at dat 3 and basal plasma citrulline
Feeding intolerance at day-3 of enteral nutrition Citrullinemia measured the first day just before initiation of enteral nutrition
Measured: Day 3
Citrullinemia and cumulative amount of enteral nutrition
Link between citrullinemia and cumulative amount of enteral nutrition administred during the first three days of ICU stay
Measured: Day 3
Citrullinemia and enteral nutrition complications occurrence
Link between citrullinemia levels and occurrence of acute mesenteric ischemia and inhalation pneumopathy during the first week of enteral nutrition
Measured: First week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start28 Nov 2019
- Primary completion27 Mar 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaël PITON, MD, Principal investigator, CHU DE BESANCON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967795
- Sponsor's protocol ID
- API/2018/93
- Acronym
- PREDICT
- Status last verified
- Jan 2025
- First submitted
- 27 May 2019
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrullinemia for the Prediction of Enteral Nutrition Tolerance Among Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03967795
- Acronym / sponsor ID
- PREDICT / API/2018/93
- Conditions
- Enteral Nutrition, Intensive Care Unit, Biomarkers
- Keywords
- ICU, enteral nutrition, tolerance, prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 30 May 2019 (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.
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.
Detailed description
Citrulline is an amino acid mainly produced by enterocytes from glutamine.
Citrullinemia ≤ 20μmol/L is a biomarker of enterocyte mass reduction, secondary to the reduction of small bowel length or secondary to villous atrophy diseases. A patient with low citrullinemia is probably at risk of enteral nutrition malabsorption.
Citrulline generation test consists of measuring the course of citrullinemia after an oral or intravenous administration of glutamine, the main precursor of citrulline. When the small bowel is functional, administration of glutamine is followed by the elevation of citrullinemia. On the contrary, when there is enterocyte dysfunction or reduction, citrullinemia does not vary after glutamine administration. Peeters et al have shown the feasibility of carrying out the citrulline generation test in patients hospitalized in the ICU. In this context, intravenous administration of glutamine (20 gr of 10% N2-L-Alanyl-L-Glutamine, dilution in 200 ml of water for injection, IV infusion over 30 minutes) followed by monitoring of citrullinemia (basal time and then after 90 minutes, on arterial sampling) is feasible and reproducible.
There is currently no data available on the relationship between citrullinemia measured at ICU admission and tolerance to enteral nutrition in the days following ICU admission. Similarly, the value of the citrulline generation test for evaluating enteral nutrition tolerance is unknown.
The investigators hypothesize that patients with low citrullinemia at ICU admission, as well as those with a decreased citrullinemia elevation after Dipeptiven bolus, will have less tolerance to enteral nutrition than patients with normal citrullinemia.
PREDICT is the first study evaluating the interest of citrullinemia and the citrulline generation test to predict feeding tolerance among critically ill patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Drug: N2-L-Alanyl-L-Glutamine (Substance)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| N2-L-Alanyl-L-Glutamine (Substance)Also: Dipeptiven20 gr of 10% N2-L-Alanyl-L-Glutamine, dilution in 200 ml of water for injection, intravenous perfusion over 30 minutes | Drug | All patients |
Primary outcome
Feeding intolerance at day-3 and citrulline generation test
Time frame: Day 3
Feeding intolerance evaluated at day-3 of enteral nutrition Citrulline generation test: variation of citrullinemia/90 minutes
3 secondary outcomes
Feeding intolerance at dat 3 and basal plasma citrulline
Time frame: Day 3
Citrullinemia and cumulative amount of enteral nutrition
Time frame: Day 3
Citrullinemia and enteral nutrition complications occurrence
Time frame: First week
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 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Gaël PITON, MD principal investigator
CHU DE BESANCON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N2-L-Alanyl-L-Glutamine (Substance) in people with Enteral Nutrition and Intensive Care Unit, run by Centre Hospitalier Universitaire de Besancon 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 6 inclusion and 4 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 16 Jan 2025. 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?
Feeding intolerance at day-3 and citrulline generation test (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2025.