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. 2018 Jun 8;2018(6):CD012276. doi: 10.1002/14651858.CD012276.pub2

NCT01802099.

Methods RCT
Participants Adults, ≥ 18 years of age, requiring mechanical ventilation for > 48 hours, treated with a vasoactive drug via a CVC, eligible for nutritional support started within 24 hours after endotracheal intubation (or within 24 hours after ICU admission if intubation occurred before ICU admission)
Interventions Early EN formula vs PN formula. EN group given EN for 8 days, then supplemental PN if required. PN group given PN for at least 72 hours, then weaned to EN if haemodynamically stable
Outcomes
  1. Mortality (28 days)

  2. VAP

  3. Bacteraemia

  4. CVC‐related complications

  5. Urinary tract infections

  6. Soft tissue infections

  7. Nosocomial infections

  8. Bacteriological data

  9. Vomiting or regurgitation

  10. Diarrhoea

  11. Bowel ischaemia

  12. Mean caloric intake

  13. Volume of liquid feed

  14. SOFA scores

  15. ICU mortality

  16. 90‐day mortality

  17. Hospital mortality

  18. Mean changes in albumin

  19. Prealbumin and C‐reactive protein

  20. Liver dysfunction episode

  21. ICU length of stay

  22. Hospital length of stay

  23. Duration of mechanical ventilation

  24. Changes in mean bodyweight

Notes Clinical trials registration ID: NCT0180299
Study terminated early due to Data Safety and Monitoring Board recommendation. Report of results prior to termination not yet published