Influence of of a Lipid Emulsion on Inflammatory Response... | NCT00600912

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

NCT00600912

Sponsor

Klinikum Ludwigshafen

Status

Completed

Last Update Posted

Dec 3, 2009Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Inflammatory Response
Hepatic Function

Interventions

SMOFlipid®
2-ClinOleic 20%®

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
kli-Lu-spiper 12-2007

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jan 14, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2009

Last Update Posted Date

Dec 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Fatty emulsions are an indispensable part of parenteral nutrition, because they deliver energy and essential fatty acids. Furthermore, lipids are involved in the structure and function of cell membranes and receptors, modifying gene expression, and modulating the inflammatory and immune response. In addition, fatty acids are precursors of prostaglandins and other eicosanoids and have therefore important metabolic functions.A promising substrate in the development of lipid emulsions can be seen in fish oils containing solutions. With regard to the current literature, fish oil have a potential benefical influence on the pathophysiological response to endotoxins and exert important modulations on eicosanoid and cytokine biology.

However, there are no studies avaibale comparing fish oil containing fatty emulsions to a lipid emulsion based on olive and soybean oil with regard to inflammatory response and hepatic function.

Therefore, the aim of this study was to evaluate the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides, olive oil and fish oil compared to a lipid emulsion based on olive and soybean oil on the inflammatory response and hepatic function in postoperative intensive care unit (ICU) patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition		5 days

Secondary Outcomes

Measure	Description	Time Frame
Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST)		5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Swen N. Piper, Dr. med.	Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine		Ludwigshafen		67063	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15141405	Background	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.
16041475	Background

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms