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Completed

NCT Number: NCT02022813

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

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.

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Key information

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Unit, Geneva University Hospital, Geneva, Canton of Geneva, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Standard industrial PN solutions

Primary outcomes

  1. Glucose and Leucine turnover

    Time frame: 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 outcomes

  1. Immune and inflammatory impact of optimized target feeding

    Time frame: 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 outcomes

  1. Global outcome

    Time frame: 28 days / 90 days

    Overall complications and organ failures, length of mechanical ventilation, length of ICU and hospital stay.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • University of Geneva, Switzerland

Registry information

Official study title

Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.

Acronym: SPN2

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 30, 2013
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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