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

NCT00512122.

Trial name or title Impact of early parenteral nutrition completing enteral nutrition in adult critically ill patients
Methods Participants randomly divided into EN or EN and early PN group. Multi‐centre study
Participants Inclusion criteria
  1. Adults admitted to any 1 of 5 ICUs

  2. NRS ≥ 3 at ICU admission


Exclusion criteria
  1. DNR code or moribund at time of ICU admission

  2. Already enrolled in another trial

  3. Transferred from another ICU with an established nutritional therapy

  4. Ketoacidotic or hyperosmolar coma on admission

  5. BMI < 17 kg/m²

  6. Short bowel syndrome

  7. Known to be pregnant or nursing

  8. On mechanical ventilation at home

  9. NRS score < 3

  10. Readmitted to ICU after randomization to the EPaNIC trial

  11. Not critically ill on admission

Interventions EN group: withholding PN during the first week of ICU stay. Participants will receive exclusively EN. If EN is insufficient after 7th day of ICU stay, PN will be started.
EN and early PN: PN will be started the morning of 3rd day of ICU stay. Amount of PN will be calculated to cover the caloric needs of the participant, based on EN energy intake during the previous 24 hours.
Outcomes
  1. Length of stay in ICU

  2. Mortality

  3. Days to weaning from mechanical ventilation

  4. Need for renal replacement therapies

  5. Presence or absence of new kidney injury during ICU stay

  6. Days of vasopressor or inotropic support

  7. Presence or absence of signs of ICU liver disease

  8. Need for tracheotomy

  9. Presence or absence of hyperinflammation within 5 days of ICU admission

  10. Blood lipid profiles and albumin on days 1, 5, 10, and 15 after admission

  11. Presence or absence of bacteraemia, ventilator‐associated pneumonia, and wound infections

  12. Episodes of hypoglycaemic events

  13. Amount and type of calories delivered

  14. Muscle strength

  15. Rehabilitation/functionality

Starting date August 2007
Contact information Greet Van den Berghe, Katholieke Universiteit Leuven
Notes Clinical trials registration ID: NCT00512122