Overview

Influence of of a Lipid Emulsion on Inflammatory Response and Hepatic Function

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
Lipid emulsions are an essential part of parenteral nutrition, both as a part of energy supply, and as a source of essential fatty acids. It has been shown that the fatty acid composition of cell membranes is influenced by the fatty acid profile of dietary lipids, and may therefore be responsible for modulation of immune response. The aim of this study was to assess the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides, olive oil and fish oil compared with a lipid emulsion based on olive and soybean oil on the inflammatory response and hepatic function in postoperative intensive care unit (ICU) patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Klinikum Ludwigshafen
Treatments:
SMOFlipid
Criteria
Inclusion Criteria:

- 18-80 years

- Elective operative procedure, and indication for parenteral nutrition over 5
postoperative days

- ASA I-III

- Haemoglobin > 10 g/dl

- Ability and acceptance to agree to the study participation

- Written informed consent

Exclusion Criteria:

- Liver insufficiency (ASAT, ALAT > 40 U/l)

- Renal insufficiency (creatinine > 1.4 mg/dl)

- Pancreas insufficiency

- Emergencies

- Women in child bearing age and missing negative pregnancy test, pregnancy or lactation

- Diseases from the central nervous system (such as M. Parkinson and multiple sclerosis)

- Alcohol and drug abuse (including opioid abuse)

- Acute pulmonary oedema

- Decompensated cardiac insufficiency

- Insulin-dependent diabetes mellitus

- Overweight (body mass index > 30 kg/m2

- Cachexia (body mass index < 18 kg/m2)

- Psychiatric disorders

- Hypersensitivity to egg, coconut or soy proteins

- Patients taking chronic corticoids

- Allergy to any of the study agents

- Refusal from the patient to participate in the study

- Participation in another study project