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

NCT00600912 | Completed Phase 4

• 2 other identifiers: SMOF 5178kli-Lu-spiper 12-2007
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Response; Hepatic Function

Keywords

lipid emulsion; fish oil; parenteral nutrition; leucotriene LTB5; hepatic function

Outcome Measures

Primary Outcomes (1)

• The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition

  5 days

Secondary Outcomes (1)

• Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST)

  5 days

Study Arms (2)

1-SMOFlipid®

EXPERIMENTAL

lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)

Drug: SMOFlipid®

2-ClinOleic 20%®

ACTIVE COMPARATOR

olive and soybean oil-group (n=21)

Drug: 2-ClinOleic 20%®

Interventions

SMOFlipid® DRUG

continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.

Also known as: SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany)

1-SMOFlipid®

2-ClinOleic 20%® DRUG

continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.

Also known as: ClinOleic 20%® (Baxter Deutschland GmbH,Unterschleissheim, Germany)

2-ClinOleic 20%®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Ludwigshafen: lead

Study Sites (1)

Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine

Ludwigshafen, 67063, Germany

Location

Related Publications (3)

• Antebi H, Mansoor O, Ferrier C, Tetegan M, Morvan C, Rangaraj J, Alcindor LG. Liver function and plasma antioxidant status in intensive care unit patients requiring total parenteral nutrition: comparison of 2 fat emulsions. JPEN J Parenter Enteral Nutr. 2004 May-Jun;28(3):142-8. doi: 10.1177/0148607104028003142.

  PMID: 15141405 BACKGROUND

• Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22.

  PMID: 16041475 BACKGROUND

• Adolph M. Lipid emulsions in parenteral nutrition. Ann Nutr Metab. 1999;43(1):1-13. doi: 10.1159/000012761.

  PMID: 10364625 BACKGROUND

MeSH Terms

Conditions

Hyperphagia

Interventions

SMOFlipid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Swen N. Piper, Dr. med.

  Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 3, 2009

Record last verified: 2009-12

Locations

DE (1)