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

BackgroundNutritional 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.Methods/DesignThe 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.DiscussionThe 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.Trial registrationClinicalTrials.gov Identifier: NCT01802099 (registered 27 February 2013)

Pediatric Multiple Organ Dysfunction Syndrome: Promising Therapies

“…Although RCT results evaluating the issue in adults have not been uniform, the preferential delivery of nutrition by the enteral route is associated with reduced 60-day mortality in critically ill children (18-23). Yet, despite early enteral nutrition (EN) guidelines, prescribed macronutrient needs fail to be met during pediatric critical illness and median daily protein and calorie delivery remains only 40-75% of goal(18, 19, 24, 25).…”

Small‐Bowel Feeding Tube Placement at Bedside: Electronic Medical Device Placement and X‐Ray Agreement

“…Adequate nutrition provision is a vital aspect of any hospitalized patient's plan of care. Patients who receive adequate nutrition have decreased mortality and improved clinical outcomes; thus it is important to provide adequate nutrition for treatment and prevention of malnutrition . The enteral route is often preferred over parenteral when the patient has a functional gastrointestinal tract.…”

“…The enteral route is often preferred over parenteral when the patient has a functional gastrointestinal tract. Recommendations suggest initiation of enteral nutrition (EN) within the first 24–48 hours of admission into the intensive care unit (ICU) . The placement of a small‐bowel feeding tube (SBFT) for enteral access can be indicated for patients exhibiting gastroparesis and pancreatitis and those with known reflux or aspiration of gastric contents and intolerance to gastric feeds …”

“…Patients who receive adequate nutrition have decreased mortality and improved clinical outcomes; thus it is important to provide adequate nutrition for treatment and prevention of malnutrition. [1][2][3] The enteral route is often preferred over parenteral when the patient has a functional gastrointestinal tract. Recommendations suggest initiation of enteral nutrition (EN) within the first 24-48 hours of admission into the intensive care unit (ICU).…”

“…Recommendations suggest initiation of enteral nutrition (EN) within the first 24-48 hours of admission into the intensive care unit (ICU). [1][2][3][4][5][6] The placement of a small-bowel feeding tube (SBFT) for enteral access can be indicated for patients exhibiting gastroparesis and pancreatitis and those with known reflux or aspiration of gastric contents and intolerance to gastric feeds. 3,6 Historically, patients requiring EN delivered beyond the stomach had a feeding tube inserted by a physician with the assistance of fluoroscopy for correct placement to confirm the tube had reached the postpyloric position in the duodenum.…”