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Clinical Trials/NCT01536275
NCT01536275Active, not recruitingNot Applicable

Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients

KU Leuven6 sites in 3 countries1,440 target enrollmentStarted: June 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
KU Leuven
Enrollment
1,440
Locations
6
Primary Endpoint
Incidence of new infection during ICU stay
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
— to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of new infection during ICU stay

Time Frame: during ICU stay and up to 90 days post-randomization

Duration of ICU dependency (crude stay days and time to alive discharge from ICU)

Time Frame: during ICU stay and up to 90 days post-randomization

Secondary Outcomes

  • Mortality(during ICU stay, hospital stay and up to 90 days post-randomization)
  • Incidence of hypoglycaemia during ICU stay(during the intervention window up to day 8 post-randomization)
  • Incidence of liver dysfunction during ICU stay(during ICU stay and up 90 days post-randomization)
  • Need for haemodynamic support during ICU stay(during ICU stay and up 90 days post-randomization)
  • Incidence of new kidney injury during ICU stay(during ICU stay and up 90 days post-randomization)
  • Number of readmissions to the ICU(up to 90 days post-randomization)
  • health economy analysis(during index hospitalization)
  • Time to alive discharge from hospital(during hospital stay and up to 90 days post-randomization)
  • Time to final weaning from mechanical respiratory support(during ICU stay and up to 90 days post-randomization)
  • Duration of antibiotics treatment during ICU stay(during ICU stay and up to 90 days post-randomization)
  • Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance(during the intervention window of 8 days and up to 90 days post-randomization)
  • Structural and or functional differences in muscle tissue during ICU stay(during ICU stay and up to 90 days post-randomization)
  • biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples(up to 4 years post-randomization)
  • functional and neurocognitive development(up to 4 years post-randomization)
  • Markers of inflammation such as C-reactive protein concentrations during ICU stay(during ICU stay and up to 90 days post-randomization)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Greet Van den Berghe

Head of Dept Intensive Care Medicine

KU Leuven

Study Sites (6)

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