Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit (PEPaNIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Katholieke Universiteit Leuven
Sponsor:
Collaborators:
Sophia Kindergeneeskunde
Stollery Children's Hospital
Information provided by (Responsible Party):
Greet Van den Berghe, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01536275
First received: February 16, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.


Condition Intervention
Critical Illness
Children
Other: Late parenteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Incidence of new infection during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Time to alive discharge from ICU [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: Yes ]
  • Time to alive discharge from hospital [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemia during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: Yes ]
  • Time to final weaning from mechanical respiratory support [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Incidence of liver dysfunction during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Need for haemodynamic support during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Incidence of new kidney injury during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Duration of antibiotics treatment during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Number of readmissions to the ICU [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Amount of calories delivered during the ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • C-reactive protein concentrations during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • Structural differences in muscle tissue during ICU stay [ Time Frame: up to 90 days post-randomization ] [ Designated as safety issue: No ]
  • biochemical, metabolic, immunological, inflammatory and (epi)genetic markers on blood samples [ Time Frame: up to 4 years post-randomization ] [ Designated as safety issue: No ]
  • functional and neurocognitive development [ Time Frame: up to 4 years post-randomization ] [ Designated as safety issue: No ]
  • health economy analysis [ Time Frame: during index hospitalization ] [ Designated as safety issue: No ]
    total health care costs during hospital stay


Estimated Enrollment: 1440
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Early parenteral nutrition
Parenteral nutrition supplements insufficient enteral nutrition from the third day of ICU stay (current standard of care)
Experimental: Late parenteral nutrition
Parenteral nutrition will be withheld during the first 7 days of ICU stay
Other: Late parenteral nutrition
Withholding parenteral nutrition during the first 7 days of ICU stay
Other Name: Late PN

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission

Exclusion Criteria:

  • Age of 17 years or older
  • Patients with a DNR code at the time of ICU admission.
  • Patients expected to die within 12 hours (=moribund patients).
  • Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge
  • Patients transferred from another paediatric intensive care after a stay of more than 7 days
  • Patients suffering from ketoacidotic or hyperosmolar coma on admission.
  • Patients suffering from Short Bowel Syndrome on home PN or other conditions that require home PN
  • Patients suspicious or established inborn metabolic diseases requiring specific diet
  • STRONGkids score lower than 2 on ICU admission.
  • Premature Newborns ( 37 weeks gestational age upon admission in the PICU)
  • Prior inclusion in another randomized controlled outcome study
  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: NCT01536275

Contacts
Contact: Tom Fivez, MD 003216340989 tom.fivez@uzleuven.be
Contact: Dieter Mesotten, MD PhD 003216340977 dieter.mesotten@med.kuleuven.be

Locations
Belgium
Dept Intensive Care Medicine Recruiting
Leuven, Belgium, 3000
Contact: Tom Fivez, MD    003216340989    tom.fivez@uzleuven.be   
Contact: Dieter Mesotten, MD PhD    003216340977    dieter.mesotten@med.kuleuven.be   
Principal Investigator: Dieter Mesotten, MD PhD         
Sub-Investigator: Sascha Verbruggen, MD, PhD         
Sub-Investigator: Tom Fivez, MD         
Sub-Investigator: Ari Joffe, MD, PhD         
Sub-Investigator: Gonzalo Garcia Guerra, MD         
Sub-Investigator: Bodil Larsen, PhD, RD         
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Ari Joffe, MD, PhD    7802485435    ari.joffe@albertahealthservices.ca   
Principal Investigator: Ari Joffe, MD, PhD         
Sub-Investigator: Gonzalo Garcia Guerra, MD         
Sub-Investigator: Bodil Larsen, PhD, RD         
Netherlands
Erasmus MC Sophia Kinderziekenhuis Recruiting
Rotterdam, Netherlands, 3015
Contact: Sascha Verbruggen, MD, PhD    0031107036669    s.verbruggen@erasmusmc.nl   
Contact: Koen Joosten, MD, PhD    0031107040704    k.joosten@erasmusmc.nl   
Sponsors and Collaborators
Katholieke Universiteit Leuven
Sophia Kindergeneeskunde
Stollery Children's Hospital
Investigators
Principal Investigator: Greet Van den Berghe, MD PhD KU Leuven
  More Information

Publications:
Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults N Engl J Med. 2011 Aug 11;365(6):506-17. Epub 2011 Jun 29.

Responsible Party: Greet Van den Berghe, Head of Dept Intensive Care Medicine, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01536275     History of Changes
Other Study ID Numbers: PEPaNIC, 2012-000811-10, ML8052, NL38772.000.12, IWT-TBM 110685
Study First Received: February 16, 2012
Last Updated: January 28, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Canada: Ethics Review Committee

Keywords provided by Katholieke Universiteit Leuven:
critical illness
children
nutrition
metabolism

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014