Dataset Information

Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2).

ABSTRACT: Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality. The primary goal of this trial is to assess the hypothesis that early first-line EN, as compared to early first-line PN, decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock.The NUTRIREA-2 study is a multicenter, open-label, parallel-group, randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48 hours, combined with vasoactive drugs, for shock. Patients will be allocated at random to first-line PN for at least 72 hours or to first-line EN. In both groups, nutritional support will be started within 24 hours after IMV initiation. Calorie targets will be 20 to 25 kcal/kg/day during the first week, then 25 to 30 kcal/kg/day thereafter. Patients receiving PN may be switched to EN after at least 72 hours in the event of shock resolution (no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2 mmol/L). On day 7, all patients receiving PN and having no contraindications to EN will be switched to EN. In both groups, supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake. We plan to recruit 2,854 patients at 44 participating ICUs.The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients. Enrollment started on 22 March 2013 and is expected to end in November 2015.ClinicalTrials.gov Identifier: NCT01802099 (registered 27 February 2013).

SUBMITTER: Brisard L

PROVIDER: S-EPMC4307984 | biostudies-other | 2014 Dec

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2).

Brisard Laurent L Le Gouge Amélie A Lascarrou Jean-Baptiste JB Dupont Hervé H Asfar Pierre P Sirodot Michel M Piton Gael G Bui Hoang-Nam HN Gontier Olivier O Hssain Ali Ait AA Gaudry Stéphane S Rigaud Jean-Philippe JP Quenot Jean-Pierre JP Maxime Virginie V Schwebel Carole C Thévenin Didier D Nseir Saad S Parmentier Erika E El Kalioubie Ahmed A Jourdain Mercé M Leray Véronique V Rolin Nathalie N Bellec Frédéric F Das Vincent V Ganster Frédérique F Guitton Christophe C Asehnoune Karim K Bretagnol Anne A Anguel Nadia N Mira Jean-Paul JP Canet Emmanuel E Guidet Bertrand B Djibre Michel M Misset Benoit B Robert René R Martino Frédéric F Letocart Philippe P Silva Daniel D Darmon Michael M Botoc Vlad V Herbrecht Jean Etienne JE Meziani Ferhat F Devaquet Jérôme J Mercier Emmanuelle E Richecoeur Jack J Martin Stéphanie S Gréau Emilie E Giraudeau Bruno B Reignier Jean J

Trials 20141223

<h4>Background</h4>Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decrease ...[more]

PMID: 25539571

Similar Datasets

Project description:BackgroundAmong patients with acute respiratory failure requiring prolonged mechanical ventilation, tracheostomies are typically placed after approximately 7 to 10 days. Yet half of patients admitted to the intensive care unit receiving tracheostomy will die within a year, often within three months. Existing mortality prediction models for prolonged mechanical ventilation, such as the ProVent Score, have poor sensitivity and are not applied until after 14 days of mechanical ventilation. We developed a model to predict 3-month mortality in patients requiring more than 7 days of mechanical ventilation using deep learning techniques and compared this to existing mortality models.MethodsRetrospective cohort study. Setting: The Medical Information Mart for Intensive Care III Database. Patients: All adults requiring ≥ 7 days of mechanical ventilation. Measurements: A neural network model for 3-month mortality was created using process-of-care variables, including demographic, physiologic and clinical data. The area under the receiver operator curve (AUROC) was compared to the ProVent model at predicting 3 and 12-month mortality. Shapley values were used to identify the variables with the greatest contributions to the model.ResultsThere were 4,334 encounters divided into a development cohort (n = 3467) and a testing cohort (n = 867). The final deep learning model included 250 variables and had an AUROC of 0.74 for predicting 3-month mortality at day 7 of mechanical ventilation versus 0.59 for the ProVent model. Older age and elevated Simplified Acute Physiology Score II (SAPS II) Score on intensive care unit admission had the largest contribution to predicting mortality.DiscussionWe developed a deep learning prediction model for 3-month mortality among patients requiring ≥ 7 days of mechanical ventilation using a neural network approach utilizing readily available clinical variables. The model outperforms the ProVent model for predicting mortality among patients requiring ≥ 7 days of mechanical ventilation. This model requires external validation.

Project description:BackgroundThe state-of-the-art nutrition used for critically ill children is based essentially on expert opinion and extrapolations from adult studies or on studies in non-critically ill children. In critically ill adults, withholding parenteral nutrition (PN) during the first week in ICU improved outcome, as compared with early supplementation of insufficient enteral nutrition (EN) with PN. We hypothesized that withholding PN in children early during critical illness reduces the incidence of new infections and accelerates recovery.Methods/designThe Pediatric Early versus Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC) study is an investigator-initiated, international, multicenter, randomized controlled trial (RCT) in three tertiary referral pediatric intensive care units (PICUs) in three countries on two continents. This study compares early versus late initiation of PN when EN fails to reach preset caloric targets in critically ill children. In the early-PN (control, standard of care) group, PN comprising glucose, lipids and amino acids is administered within the first days to reach the caloric target. In the late-PN (intervention) group, PN completing EN is only initiated beyond PICU-day 7, when EN fails. For both study groups, an early EN protocol is applied and micronutrients are administered intravenously. The primary assessor-blinded outcome measures are the incidence of new infections during PICU-stay and the duration of intensive care dependency. The sample size (n = 1,440, 720 per arm) was determined in order to detect a 5% absolute reduction in PICU infections, with at least 80% 1-tailed power (70% 2-tailed) and an alpha error rate of 5%. Based on the actual incidence of new PICU infections in the control group, the required sample size was confirmed at the time of an a priori- planned interim-analysis focusing on the incidence of new infections in the control group only.DiscussionClinical evidence in favor of early administration of PN in critically ill children is currently lacking, despite potential benefit but also known side effects. This large international RCT will help physicians to gain more insight in the clinical effects of omitting PN during the first week of critical illness in children.Trial registrationClinicalTrials.gov: NCT01536275 on 16 February 2012.

Dataset Information

Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2).

Publications

Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets