Inflammatory ResponsePhase 4NCT00600912

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

A Phase 4 study testing SMOFlipid® and 2-ClinOleic 20%® in people with Inflammatory Response and Hepatic Function, run by Klinikum Ludwigshafen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Inflammatory Response, Hepatic Function
What is being tested?: SMOFlipid® and 2-ClinOleic 20%®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteGermany
Study dates: Dec 2006to Dec 2007
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Ludwigshafen, 67063

Other trials in Germany

About this study

Official title: Inflammatory Response and Hepatic Function in Patients Requiring Parenteral Nutrition: Comparison of a Lipid Emulsion Based ob Soybean Oil, Medium-Chain Triglycerides, Olive Oil and Fish Oil Versus a Lipid Emulsion Based on Olive and Soybean Oil

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.

Read the 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.

Conditions: Inflammatory Response, Hepatic Function
Being tested: SMOFlipid®, 2-ClinOleic 20%®
Keywords: lipid emulsion, fish oil, parenteral nutrition, leucotriene LTB5, hepatic function
Medical subject headings: Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMOFlipid®Drug
Also called SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany)
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.
2-ClinOleic 20%®Drug
Also called ClinOleic 20%® (Baxter Deutschland GmbH,Unterschleissheim, Germany)
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.

Study groups in NCT00600912
Study group	Role	What they receive
1-SMOFlipid®	Experimental	lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21) Receives: Drug: SMOFlipid®
2-ClinOleic 20%®	Active comparator	olive and soybean oil-group (n=21) Receives: Drug: 2-ClinOleic 20%®

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition
Measured: 5 days

Secondary outcomes (1)

Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST)
Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Dec 2007

First posted25 Jan 2008 (estimated)
Study startDec 2006
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00600912
Sponsor's protocol ID: SMOF 5178
Other IDs: kli-Lu-spiper 12-2007
Status last verified: Dec 2009
First submitted: 14 Jan 2008
Last updated: 3 Dec 2009
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 15141405
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.
PubMed 16041475
Adolph M. Lipid emulsions in parenteral nutrition. Ann Nutr Metab. 1999;43(1):1-13. doi: 10.1159/000012761.
PubMed 10364625

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inflammatory Response and Hepatic Function in Patients Requiring Parenteral Nutrition: Comparison of a Lipid Emulsion Based ob Soybean Oil, Medium-Chain Triglycerides, Olive Oil and Fish Oil Versus a Lipid Emulsion Based on Olive and Soybean Oil
ClinicalTrials.gov ID: NCT00600912
Acronym / sponsor ID: SMOF 5178
Conditions: Inflammatory Response, Hepatic Function
Keywords: lipid emulsion, fish oil, parenteral nutrition, leucotriene LTB5, hepatic function
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Klinikum LudwigshafenUniversity, hospital or other
Study start: Dec 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 25 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
1-SMOFlipid®	Experimental	Drug: SMOFlipid®lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)
2-ClinOleic 20%®	Active comparator	Drug: 2-ClinOleic 20%®olive and soybean oil-group (n=21)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SMOFlipid®Also: SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany)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.	Drug	1-SMOFlipid®
2-ClinOleic 20%®Also: ClinOleic 20%® (Baxter Deutschland GmbH,Unterschleissheim, Germany)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.	Drug	2-ClinOleic 20%®

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
Background: PubMed 15141405Antebi 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.
Background: PubMed 16041475Grimm 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.
Background: PubMed 10364625Adolph M. Lipid emulsions in parenteral nutrition. Ann Nutr Metab. 1999;43(1):1-13. doi: 10.1159/000012761.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Swen N. Piper, Dr. med. principal investigator

Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SMOFlipid® and 2-ClinOleic 20%® in people with Inflammatory Response and Hepatic Function, run by Klinikum Ludwigshafen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00600912, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2009.