Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses
- Conditions
- Critical Illness
- Interventions
- Dietary Supplement: Supplemental parenteral nutrition (SPN)
- Registration Number
- NCT02022813
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supplemental parenteral nutrition Supplemental parenteral nutrition (SPN) Addition of supplemental parenteral nutrition to complete the gap between energy delivered by enteral feeding and energy target measured on day 4. Aim: 100% of this target, and not exceeding it, no catch up for energy deficit accumulated before day 4.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Nutrition Unit, Geneva University Hospital
🇨🇭Geneva, GE, Switzerland
Service of Adult Intensive Care - CHUV
🇨🇭Lausanne, VD, Switzerland