Protein and Energy Interactions in Critically Ill Childre
- Conditions
- 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: 9.1Level: LLTClassification code 10022489Term: Insulin resistance
- Registration Number
- EUCTR2009-010999-19-NL
- Lead Sponsor
- Erasmus MC - Sophia Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
-Metabolic disease (eg Diabetes Mellitus)
-Enteral feeding
-Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method