Acute Respiratory FailureNCT03411447
Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines
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 evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions 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
- 139 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Jan 2015to 7 Jul 2015
- 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
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
CHU Louis Mourier
Colombes
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 Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions
Read the detailed description
A common obstacle to enteral nutrition is gastrointestinal intolerance, with regurgitations potentially responsible for gastric-content aspiration. Several studies involving technetium 99m (99mTc) labeling of gastric contents have established that gastric-fluid microaspiration is common in critically ill patients receiving both endotracheal ventilation and enteral nutrition. However, to our knowledge, no studies have specifically addressed the role for enteral nutrition in the occurrence of microaspiration. The objective of this ancillary study is to compare the frequency of gastric-content microaspiration in patients given enteral versus parenteral nutrition during the NUTRIREA2 trial. The new knowledge of risk factors for microaspiration provided by this study may help to improve strategies for preventing microaspiration and ventilator-associated pneumonia (VAP).
- 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 | Active comparator | 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 | Active comparator | 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.
proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates)
Every tracheal aspirate will be collected during 48hours following randomisation
Measured: 48Hours following randomisation
Secondary outcomes (1)
Salivary amylase levels in tracheal aspirates.
Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed.
Measured: 48Hours following randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start27 Jan 2015
- Primary completion7 Jul 2015
- Study completion7 Jul 2015
Why it stopped: stopped on 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 139 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
- NCT03411447
- Sponsor's protocol ID
- CHD085-13
- Status last verified
- Jan 2018
- First submitted
- 18 Jul 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nseir S, Le Gouge A, Lascarrou JB, Lacherade JC, Jaillette E, Mira JP, Mercier E, Declercq PL, Sirodot M, Piton G, Tinturier F, Coupez E, Gaudry S, Djibre M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J. Impact of nutrition route on microaspiration in critically ill patients with shock: a planned ancillary study of the NUTRIREA-2 trial. Crit Care. 2019 Apr 5;23(1):111. doi: 10.1186/s13054-019-2403-z.
PubMed 30953553
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
- ClinicalTrials.gov ID
- NCT03411447
- Acronym / sponsor ID
- CHD085-13
- 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: stopped on Data Safety and Monitoring Board 's request
- Enrolment
- 139 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
- 7 Jul 2015 (actual)
- First posted
- 26 Jan 2018 (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 evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions
Detailed description
A common obstacle to enteral nutrition is gastrointestinal intolerance, with regurgitations potentially responsible for gastric-content aspiration. Several studies involving technetium 99m (99mTc) labeling of gastric contents have established that gastric-fluid microaspiration is common in critically ill patients receiving both endotracheal ventilation and enteral nutrition. However, to our knowledge, no studies have specifically addressed the role for enteral nutrition in the occurrence of microaspiration. The objective of this ancillary study is to compare the frequency of gastric-content microaspiration in patients given enteral versus parenteral nutrition during the NUTRIREA2 trial. The new knowledge of risk factors for microaspiration provided by this study may help to improve strategies for preventing microaspiration and ventilator-associated pneumonia (VAP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition | Active comparator | 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 | Active comparator | 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 (3 listed)
- Abdominal surgery within 1 month before inclusion
- History of esophageal, gastric, duodenal or pancreatic surgery
- Bleeding from the esophagus, stomach or bowel
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
proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates)
Time frame: 48Hours following randomisation
Every tracheal aspirate will be collected during 48hours following randomisation
1 secondary outcome
Salivary amylase levels in tracheal aspirates.
Time frame: 48Hours following randomisation
Results and safety
The study was stopped early (reason given: stopped on 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 26 Jan 2018.
- Derived from this study: PubMed 30953553Nseir S, Le Gouge A, Lascarrou JB, Lacherade JC, Jaillette E, Mira JP, Mercier E, Declercq PL, Sirodot M, Piton G, Tinturier F, Coupez E, Gaudry S, Djibre M, Thevenin D, Pasco J, Balduyck M, Zerimech F, Reignier J. Impact of nutrition route on microaspiration in critically ill patients with shock: a planned ancillary study of the NUTRIREA-2 trial. Crit Care. 2019 Apr 5;23(1):111. doi: 10.1186/s13054-019-2403-z.
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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 3 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 26 Jan 2018. 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: stopped on 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?
proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates) (time frame: 48Hours following randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411447, which also lists 1 linked publication.
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 26 Jan 2018.