Clinical trial NCT02022813: Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses
Official title: Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Energy requirements, Glucose turnover, Protein turnover
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2013-12-30
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose and Leucine turnover
timeFrame: 10 days
Secondary outcomes:
measure: Immune and inflammatory impact of optimized target feeding
timeFrame: 10 days
Other outcomes:
measure: Global outcome
timeFrame: 28 days / 90 days
Locations:
city: Geneva
country: Switzerland
facility: Nutrition Unit, Geneva University Hospital
state: GE
city: Lausanne
country: Switzerland
facility: Service of Adult Intensive Care - CHUV
state: VD
Study officials:
affiliation: CHUV, Lausanne
name: Mette M Berger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2012 Dec 3.
citation: Berger MM, Pantet O, Jacquelin-Ravel N, Charriere M, Schmidt S, Becce F, Audran R, Spertini F, Tappy L, Pichard C. Supplemental parenteral nutrition improves immunity with unchanged carbohydrate and protein metabolism in critically ill patients: The SPN2 randomized tracer study. Clin Nutr. 2019 Oct;38(5):2408-2416. doi: 10.1016/j.clnu.2018.10.023. Epub 2018 Nov 5.