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stopped on Data Safety and Monitoring Board 's request
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University Hospital, Tours | OTHER |
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To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Enteral nutrition | Active Comparator | Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral nutrition | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48Hours following randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary amylase levels in tracheal aspirates. | Every tracheal aspirate will be collected during 48hours following randomisation. Salivary amylase will be analysed. | 48Hours following randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean REIGNIER, MD, PhD | CHD Vendee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France | |||
| Centre hospitalier d'Annecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30953553 | Derived | 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. |
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| Enteral nutrition |
| Other |
|
|
| Annecy |
| 74374 |
| France |
| CHU Louis Mourier | Colombes | France |
| CHU Lille | Lille | 59000 | France |
| CHU Saint Louis | Paris | 75010 | France |
| CHU Tours | Tours | 37044 | France |
| ID | Term |
|---|---|
| D012769 | Shock |
| D006963 | Hyperphagia |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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