Critical Illness Clinical Trial
Official title:
Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.
Having previously demonstrated that supplemental parenteral nutrition to complete an insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical illness, by reducing infectious complications, the present trial aims at investigating the underlying carbohydrate and protein metabolism changes, as well as the immune and inflammatory modulations associated with this improvement.
Enrollment on day 3 of critically ill patients, without contraindication to EN, not achieving
60% of the ICU per protocol energy target.
Intervention: Randomization to either continued pure EN, or from day 4 to supplemental PN to
complete EN at target validated by indirect calorimetry.
Measurements: Indirect calorimetry on Days 3, 4, 9 (twice). Primary endpoints = glucose and
leucine metabolism On days 4 and 9-10: isotopic investigation of glucose metabolism, and
immune and inflammatory responses// Day 9-10: isotopic investigation of protein (leucine)
metabolism Secondary endpoints: Insulin requirements, area under the curve (AUC) of blood
Glucose, infections after day 9, overall complications, length of mechanical ventilation, of
ICU and hospital stay.
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