Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses (SPN2)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.|
- Glucose and Leucine turnover [ Time Frame: 10 days ] [ Designated as safety issue: No ]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
- Immune and inflammatory impact of optimized target feeding [ Time Frame: 10 days ] [ Designated as safety issue: No ]
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
- Global outcome [ Time Frame: 28 days / 90 days ] [ Designated as safety issue: Yes ]Overall complications and organ failures, length of mechanical ventilation, length of ICU and hospital stay.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Enteral nutrition only
Enteral nutrition to be progressed as soon as possible to energy target measured on day 3, and verified on day 4, using the usual facilitators (prokinetics)
Experimental: Supplemental parenteral nutrition
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.
Dietary Supplement: Supplemental 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
Other Name: Standard industrial PN solutions
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02022813
|Contact: Mette M Berger, MD PhD||+41 21 31 42 095||Mette.Berger@chuv.ch|
|Contact: Claude Pichard, MD PhD||+41 22 372 93 45||Claude.Pichard@unige.ch|
|Nutrition Unit, Geneva University Hospital||Active, not recruiting|
|Geneva, GE, Switzerland, 1211|
|Service of Adult Intensive Care - CHUV||Recruiting|
|Lausanne, VD, Switzerland, 1011|
|Contact: Mette M Berger, MD PhD +41 21 31 42 095 Mette.Berger@chuv.ch|
|Contact: Luc Tappy, Md PhD +41 21 692 55 41 Luc.Tappy@unil.ch|
|Principal Investigator: Mette M Berger, MD PhD|
|Sub-Investigator: Francois Spertini, MD|
|Sub-Investigator: Luc Tappy, MD PhD|
|Principal Investigator:||Mette M Berger, MD PhD||CHUV, Lausanne|