Energy metabolism of critically ill children treated with lipid emulsion and carnitine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001762-13-DE

Enrollment

Registered

2005-07-05

Start date

2005-07-13

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The primary purpose of the study is an examination of the ability of lipid emulsions and carnitin supplementation to reduce the morbidity associated with sepsis and catabolic conditions by altering energy balance, in addition to limiting catabolism in critically ill children and neonates.

Interventions

Trade Name: Lipovenös® 20% Product Name: Lipovenös 20% Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Glycerol Concentration unit: g/l gram(s)/litre Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria - all infants admitted in the ICU with the diagnosis: - a) sepsis (sepsis definition: Goldstein B 2005) - b) perinatal asphyxia (asphyxia definition: Low J 1997) - c) severe illness e.g. multitrauma 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: Exclusion Criteria Premature infants Infants with cerebral palsy (ICP) and seizures Dialysis Congenital heart failure Chromosomal anomalies

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary purpose of the study is an examination of the ability of lipid emulsions and carnitine supplementation to reduce the morbidity associated with sepsis, as-phyxia and catabolic state by altering energy balance, in addition to limiting catabo-lism in critically ill children and neonates. Energy balance would be calculated by measurements of energy expenditure using indirect calorimetry. ;Secondary Objective: The secondary aim of the study is to investigate the effect of intravenous lipids on-immunologic functions in catabolic infants. ;Primary end point(s): Therefore, the provision of nutritional and metabolic support has become essential in the care for critically ill and catabolic patients. A number of reports showed that inadequate provision of nutrients is associated with increased physiologic instability and increased care of severe ill patients (Hasselmann M 2004, Mackenzie SL 2005). Changes of energy metabolism and morbidity in critically ill children treated with lipid emulsions and carnitine are the end points of the study.	—

Measure

Time frame

Main Objective: The primary purpose of the study is an examination of the ability of lipid emulsions and carnitine supplementation to reduce the morbidity associated with sepsis, as-phyxia and catabolic state by altering energy balance, in addition to limiting catabo-lism in critically ill children and neonates. Energy balance would be calculated by measurements of energy expenditure using indirect calorimetry. ;Secondary Objective: The secondary aim of the study is to investigate the effect of intravenous lipids on-immunologic functions in catabolic infants. ;Primary end point(s): Therefore, the provision of nutritional and metabolic support has become essential in the care for critically ill and catabolic patients. A number of reports showed that inadequate provision of nutrients is associated with increased physiologic instability and increased care of severe ill patients (Hasselmann M 2004, Mackenzie SL 2005). Changes of energy metabolism and morbidity in critically ill children treated with lipid emulsions and carnitine are the end points of the study.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026