An interventional study of Late parenteral nutrition in Critical Illness and Children, sponsored by KU Leuven. Active, not recruiting at 3 sites in 3 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by KU Leuven · Not applicable, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 1,440 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center
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
Also known as: Late PN
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
Mortality
Time frame: during ICU stay, hospital stay and up to 90 days post-randomization
Time to alive discharge from hospital
Time frame: during hospital stay and up to 90 days post-randomization
Incidence of hypoglycaemia during ICU stay
Time frame: during the intervention window up to day 8 post-randomization
Time to final weaning from mechanical respiratory support
Time frame: during ICU stay and up to 90 days post-randomization
Incidence of liver dysfunction during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Need for haemodynamic support during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Incidence of new kidney injury during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Duration of antibiotics treatment during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
Number of readmissions to the ICU
Time frame: up to 90 days post-randomization
Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance
Time frame: during the intervention window of 8 days and up to 90 days post-randomization
Markers of inflammation such as C-reactive protein concentrations during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
Structural and or functional differences in muscle tissue during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples
with healthy matched control group
Time frame: up to 4 years post-randomization
functional and neurocognitive development
with healthy matched control group
Time frame: up to 4 years post-randomization
health economy analysis
total health care costs during hospital stay
Time frame: during index hospitalization
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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KU Leuven