Acute Respiratory FailureNCT03852940
Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamine
A study testing Parenteral nutrition and Enteral Nutrition in people with Acute Respiratory Failure and Shock, run by Centre Hospitalier Departemental Vendee at 6 sites in France.
Trial summary
To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Shock
- What is being tested?
- Parenteral nutrition and Enteral Nutrition
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Jan 2015to Jul 2017
- 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
- Invasive mechanical ventilation expected to be required more than 48 hours
- Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
- Treatment with vasoactive drug administered via a central venous catheter
- Age over 18 years
- Signed information
Who cannot join
- Abdominal surgery within 1 month before inclusion
- History of esophageal, gastric, duodenal or pancreatic surgery
- Bleeding from the esophagus, stomach or bowel
- enteral nutrition via gastrostomy or jejunostomy
- pregnancy
- Treatment-limitation decisions
- Current inclusion in a trial on comparison between enteral and parenteral nutrition
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Amiens
Amiens, 80054
Centre hospitalier d'Annecy
Annecy, 74374
CH de Dieppe
Dieppe, 76202
CHU Lille
Lille, 59000
CHU Saint Louis
Paris, 75010
CHU Tours
Tours, 37044
About this study
Official title: Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition
Read the detailed description
Published data suggest that enteral nutrition may be associated with improved preservation of the gut lymphoid tissues and gut immune function, as well as with decreased gut mucosa permeability, thereby diminishing the risk of organ failure. Citrulline is an amino acid produced from glutamine by small-bowel enterocytes. Plasma citrulline levels reflect functional enterocyte mass. Intestinal fatty acid-binding protein (I-FABP, also known as FABP2) is a small protein found in the cytosol of small-bowel enterocytes. Plasma I-FABP is normally undetectable and, when elevated, constitutes a reliable marker for enterocyte damage. The hypothesis underlying this ancillary study is that first-line enteral nutrition is associated with improved gut mucosa integrity and function compared to parenteral nutrition.
- Conditions
- Acute Respiratory Failure, Shock
- Being tested
- Parenteral nutrition, Enteral Nutrition
- Keywords
- vasoactive drug, mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality, shock
- Medical subject headings
- Shock, Hyperphagia, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutritionOther
Also called Intravenous nutrition, intravenous feeding
Enteral NutritionOther
Also called Enteral feeding
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition | Other | Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level < 2 mmol/l). After Day 7, all patients will be fed via the enteral route. Receives: Other: Parenteral nutrition |
| Enteral nutrition | Other | Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. Receives: Other: Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma citrulline level
Measured: 72 hours
Secondary outcomes (10)
SOFA score
Measured: first week
plasma levels of citrulline
Measured: Day 0, Day 3, Day 8
I-FABP
Measured: Day 0, Day 3, Day 8
proportion of patients whose plasma I-FABP is ≥100 pg/mL
Measured: Day 0, Day 3, Day 8
proportion of patients whose plasma citrulline is ≤10 μL/L
Measured: Day 0, Day 3, Day 8
mean plasma I-FABP
Measured: Day 0, Day 3, Day 8
mean plasma citrulline
Measured: Day 0, Day 3, Day 8
proportion of patients with at least one episode of bacteremia
Measured: until discharge from ICU (average: 10 days)
proportion of patients with at least one episode of gastrointestinal intolerance
Measured: until discharge from ICU (average: 10 days)
proportion of patients with at least one episode of diarrhea
Measured: until discharge from ICU (average: 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start27 Jan 2015
- Primary completion7 Jul 2015
- Study completionJul 2017
Why it stopped: Data Safety and Monitoring Board 's request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean REIGNIER, MD, PhD, Principal investigator, CHD Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852940
- Sponsor's protocol ID
- CHD085-12
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
- ClinicalTrials.gov ID
- NCT03852940
- Acronym / sponsor ID
- CHD085-12
- Conditions
- Acute Respiratory Failure, Shock
- Keywords
- vasoactive drug, mechanical ventilation, early enteral nutrition, intensive care unit, early parenteral nutrition, critical care medicine, nosocomial infection, mortality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data Safety and Monitoring Board 's request
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 7 Jul 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Feb 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.
To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition
Detailed description
Published data suggest that enteral nutrition may be associated with improved preservation of the gut lymphoid tissues and gut immune function, as well as with decreased gut mucosa permeability, thereby diminishing the risk of organ failure. Citrulline is an amino acid produced from glutamine by small-bowel enterocytes. Plasma citrulline levels reflect functional enterocyte mass. Intestinal fatty acid-binding protein (I-FABP, also known as FABP2) is a small protein found in the cytosol of small-bowel enterocytes. Plasma I-FABP is normally undetectable and, when elevated, constitutes a reliable marker for enterocyte damage. The hypothesis underlying this ancillary study is that first-line enteral nutrition is associated with improved gut mucosa integrity and function compared to parenteral nutrition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition | Other | Other: Parenteral nutritionPatients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level < 2 mmol/l). After Day 7, all patients will be fed via the enteral route. |
| Enteral nutrition | Other | Other: Enteral NutritionPatients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Invasive mechanical ventilation expected to be required more than 48 hours
- Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
- Treatment with vasoactive drug administered via a central venous catheter
- Age over 18 years
- Signed information
Key exclusion criteria (7 listed)
- Abdominal surgery within 1 month before inclusion
- History of esophageal, gastric, duodenal or pancreatic surgery
- Bleeding from the esophagus, stomach or bowel
- enteral nutrition via gastrostomy or jejunostomy
- pregnancy
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 |
|---|---|---|
| Parenteral nutritionAlso: Intravenous nutrition, intravenous feeding | Other | Parenteral nutrition |
| Enteral NutritionAlso: Enteral feeding | Other | Enteral nutrition |
Primary outcome
Plasma citrulline level
Time frame: 72 hours
10 secondary outcomes
SOFA score
Time frame: first week
plasma levels of citrulline
Time frame: Day 0, Day 3, Day 8
I-FABP
Time frame: Day 0, Day 3, Day 8
proportion of patients whose plasma I-FABP is ≥100 pg/mL
Time frame: Day 0, Day 3, Day 8
proportion of patients whose plasma citrulline is ≤10 μL/L
Time frame: Day 0, Day 3, Day 8
mean plasma I-FABP
Time frame: Day 0, Day 3, Day 8
mean plasma citrulline
Time frame: Day 0, Day 3, Day 8
proportion of patients with at least one episode of bacteremia
Time frame: until discharge from ICU (average: 10 days)
proportion of patients with at least one episode of gastrointestinal intolerance
Time frame: until discharge from ICU (average: 10 days)
proportion of patients with at least one episode of diarrhea
Time frame: until discharge from ICU (average: 10 days)
Results and safety
The study was stopped early (reason given: Data Safety and Monitoring Board 's request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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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.
Jean REIGNIER, MD, PhD principal investigator
CHD Vendee
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral nutrition and Enteral Nutrition in people with Acute Respiratory Failure and Shock, run by Centre Hospitalier Departemental Vendee at 6 sites 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 was stopped early (reason given: Data Safety and Monitoring Board 's request). Results are not available in the source record.
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?
Plasma citrulline level (time frame: 72 hours). 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 25 Feb 2019.