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

N/ACompletedNCT02022813

Centre Hospitalier Universitaire Vaudois28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Critical Illness

Interventions

Supplemental parenteral nutrition (SPN)DIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Nutrition Unit, Geneva University Hospital

Geneva, Canton of Geneva, Switzerland

Service of Adult Intensive Care - CHUV

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

Glucose and Leucine turnover

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

Time frame: 10 days

Secondary Outcomes

Immune and inflammatory impact of optimized target feeding

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

Time frame: 10 days

Data from ClinicalTrials.gov

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