We want to study protein, glucose and lipid metabolism in critically ill septic children admitted to the PICU. As these children often receive insulin because of hyperglycemia due to insulin resistance, we want to study the effect of different nutritional regimens and insulin on their metabolism. MedDRA version: 9.1 Level: LLT Classification code 10022489 Term: Insulin resistance
Conditions
Interventions
Trade Name: Actrapid Insulin
Product Name: Actrapid
Product Code: EU/1/02/230/003-004, 017
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061680
Current Spo
Sponsors
Erasmus MC - Sophia Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -admitted to the PICU / NICU -Diagnosed with sepsis or SIRS -Indwelling central venous / arterial lines -Parenteral nutrition -Hyperglycemia Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Metabolic disease (eg Diabetes Mellitus) -Enteral feeding -Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To determine the effect of different protein intakes and the effect of insulin on whole body protein balance.;Main Objective: To assess insulin sensitivity and the effect of protein nutrition and insulin in critically ill children;Secondary Objective: To determine the relationship between protein turn over and glucose and fat metabolism in critically ill children | — |
Countries
Netherlands
Outcome results
None listed