Trial record 8 of 81 for:    Open Studies | parenteral nutrition

Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses (SPN2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Hospitalier Universitaire Vaudois
Sponsor:
Collaborator:
University of Geneva, Switzerland
Information provided by (Responsible Party):
Mette M Berger, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT02022813
First received: November 25, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Critical Illness
Dietary Supplement: Supplemental parenteral nutrition (SPN)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of Supplemental Parenteral Nutrition (SPN) on Energy Balance, and Infection Rate in Intensive Care Patients: Underlying Metabolic, Inflammatory and Immune Mechanisms.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Glucose and Leucine turnover [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Immune and inflammatory impact of optimized target feeding [ Time Frame: 10 days ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Global outcome [ Time Frame: 28 days / 90 days ] [ Designated as safety issue: Yes ]
    Overall complications and organ failures, length of mechanical ventilation, length of ICU and hospital stay.


Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Enteral nutrition only
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)
Experimental: Supplemental parenteral nutrition

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)
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 Name: Standard industrial PN solutions

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

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022813

Contacts
Contact: Mette M Berger, MD PhD +41 21 31 42 095 Mette.Berger@chuv.ch
Contact: Claude Pichard, MD PhD +41 22 372 93 45 Claude.Pichard@unige.ch

Locations
Switzerland
Nutrition Unit, Geneva University Hospital Active, not recruiting
Geneva, GE, Switzerland, 1211
Service of Adult Intensive Care - CHUV Recruiting
Lausanne, VD, Switzerland, 1011
Contact: Mette M Berger, MD PhD    +41 21 31 42 095    Mette.Berger@chuv.ch   
Contact: Luc Tappy, Md PhD    +41 21 692 55 41    Luc.Tappy@unil.ch   
Principal Investigator: Mette M Berger, MD PhD         
Sub-Investigator: Francois Spertini, MD         
Sub-Investigator: Luc Tappy, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University of Geneva, Switzerland
Investigators
Principal Investigator: Mette M Berger, MD PhD CHUV, Lausanne
  More Information

Publications:
Responsible Party: Mette M Berger, Prof, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02022813     History of Changes
Other Study ID Numbers: CE 371-13
Study First Received: November 25, 2013
Last Updated: June 19, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Energy requirements, Glucose turnover, Protein turnover

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014