NCT02022813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

November 25, 2013

Last Update Submit

February 16, 2018

Conditions

Critical Illness

Keywords

Energy requirements, Glucose turnover, Protein turnover

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Immune and inflammatory impact of optimized target feeding

    10 days

Other Outcomes (1)

  • Global outcome

    28 days / 90 days

Study Arms (2)

Enteral nutrition only

NO INTERVENTION

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)

Supplemental parenteral nutrition

EXPERIMENTAL

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)

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

Also known as: Standard industrial PN solutions
Supplemental parenteral nutrition

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nutrition Unit, Geneva University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Location

Service of Adult Intensive Care - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 23218813BACKGROUND

  • 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.

    PMID: 30448193DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mette M Berger, MD PhD

    CHUV, Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 30, 2013

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

June 1, 2017

Last Updated

February 19, 2018

Record last verified: 2016-02

Locations

CH(2)