Critical Illness
Conditions
Keywords
Energy requirements, Glucose turnover, Protein turnover
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSupplemental parenteral nutrition (SPN)
The amount of energy delivered by SPN will depend on the indirect calorimetry measurement and actual enteral feed delivery. SPN will be reduced with progressing EN
Sponsors
University of Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* estimated duration of ICU stay \> 5 days, * estimated survival \> 7 days, * absence of contraindication to EN * need for mechanical ventilation * informed consent obtained from patients, close relative, or referring physician
Exclusion criteria
* refusal of the patient or of the next of kin * age \< 18 years * non-functional digestive tract (short bowel, persistent ileus, proximal intestinal fistula high rate \> 1.5 litres/day) * already receiving PN before Day 3 * absence of a central venous catheter * women who are pregnant (pregnancy test). * Admission after cardiac arrest, or severe brain injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose and Leucine turnover | 10 days | On D04:Infusion after priming of 6.6 2H2 glucose and NaH13CO3 On Day 09-10: Infusion after priming of NaH13CO3 and of L-\[1-13C\]-Leucine + repeat of the glucose sequence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune and inflammatory impact of optimized target feeding | 10 days | lymphocyte phenotypes: lymphocyte subpopulations (frequency), level of activation (CD69), memory markers, effectors, regulators * Cluster differentiation CD4, CD8, and natural killer (NK) phenotypes * Cell inflammatory response (WBA and PBMC) on D4 and D10±1: IL-2, TNF-α, interleukine-6 (IL-6), IL-1, TGF, IL-10, in culture for 24 to 48h ex vivo and post stimulation by memory mix and mitogens. * Serological inflammatory response (WBA and PBMC) on D4 and D10+1: TNF-α , IL-6, C-reactive protein (CRP): ex vivo with ELISA Nosocomial infections after day 8 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global outcome | 28 days / 90 days | Overall complications and organ failures, length of mechanical ventilation, length of ICU and hospital stay. |
Countries
Switzerland
Outcome results
None listed