Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses

NCT ID: NCT02022813


Title
Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.
Purpose
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.
Details
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.
Conditions
Critical Illness
Keywords
Energy requirements, Glucose turnover, Protein turnover
Source
Centre Hospitalier Universitaire Vaudois
Sponsors
Centre Hospitalier Universitaire Vaudois, University of Geneva, Switzerland
Status
Recruiting
Acronym
SPN2
Last Updated
17 Feb 2016
URL
Official Link
Citations/Publications
Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8.

Locations
Switzerland