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Enteral vs parenteral early nutrition in ventilated adults with shock: A randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2)

The Lancet Nov 13, 2017

Reignier J, et al. - The proposition explored herein was that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition. It was reported that early isocaloric enteral nutrition did not reduce mortality or the risk of secondary infections, among critically ill adults with shock. Nevertheless, it correlated with a greater risk of digestive complications compared with early isocaloric parenteral nutrition.

Methods

  • The design of this research was a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2 trial).
  • It was performed at 44 French intensive-care units (ICUs) on adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock.
  • The enrollees were randomly allocated (1:1) to either parenteral nutrition or enteral nutrition, both targeting normocaloric goals (20-25 kcal/kg per day), within 24 h after intubation.
  • Randomisation was stratified by centre via permutation blocks of variable sizes.
  • Since the route of nutrition could not be masked, blinding of the physicians and nurses did not appear to be feasible.
  • Herein, the patients receiving parenteral nutrition could be switched to enteral nutrition after at least 72 h in the event of shock resolution (no vasopressor support for 24 consecutive hours and arterial lactate <2 mmol/L).
  • The primary endpoint comprised of the mortality on day 28 after randomisation in the intention-to-treat-population.

Results

  • The independent Data Safety and Monitoring Board deemed that completing patient enrolment was unlikely to substantially alter the results of the trial and suggested the discontinuation of the patient recruitment, after the second interim analysis.
  • It was noted that between March 22, 2013, and June 30, 2015, 2,410 patients were recruited and randomly assigned; 1202 to the enteral group and 1208 to the parenteral group.
  • The findings revealed that 443 (37%) of 1,202 patients in the enteral group and 422 (35%) of 1,208 patients in the parenteral group had died (absolute difference estimate 2.0%; [95% CI -1.9 to 5.8]; p=0.33), by day 28.
  • No variation was reported in the cumulative incidence of patients with ICU-acquired infections, between the enteral group (173 [14%]) and the parenteral group (194 [16%]; hazard ratio [HR] 0.89 [95% CI 0.72-1.09]; p=0.25).
  • The enteral group illustrated higher cumulative incidences of patients with vomiting (406 [34%] vs 246 [20%]; HR 1.89 [1.62-2.20]; p<0.0001), diarrhoea (432 [36%] vs 393 [33%]; 1.20 [1.05-1.37]; p=0.009), bowel ischaemia (19 [2%] vs five [<1%]; 3.84 [1.43-10.3]; p=0.007), and acute colonic pseudo-obstruction (11 [1%] vs three [<1%]; 3.7 [1.03-13.2; p=0.04), compared with the parenteral group.

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