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

Critical Illness Clinical Trial

— SPN2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022813
• Other study ID #: CE 371-13
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: February 16, 2018
• Start date: April 2014
• Est. completion date: June 2017

Study information

• Verified date: February 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Switzerland	Nutrition Unit, Geneva University Hospital	Geneva	GE
Switzerland	Service of Adult Intensive Care - CHUV	Lausanne	VD

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global outcome	Overall complications and organ failures, length of mechanical ventilation, length of ICU and hospital stay.	28 days / 90 days
Primary	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	10 days
Secondary	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-a, 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-a , IL-6, C-reactive protein (CRP): ex vivo with ELISA Nosocomial infections after day 8	10 days