Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery

Study Overview
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Brief Summary
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Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.

Official Title
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A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.

Conditions
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GI Cancer

Intervention / Treatment
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* Drug: MLF 541
* Drug: Lipofundin MCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients considered for major surgery for gastric and colorectal cancer expected requirement for post operative PN or TPN of at least 7 days possibility of PN/TPN provision 1 day prior to surgery Age >18 years old and <80 years old Hemodynamically stable Written Informed consent Exclusion Criteria: Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study Patients with sepsis, severe sepsis or septic shock Known or suspected drug abuse Intrahepatic cholestasis General contraindications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency Pregnancy (positive in urine) or lactation Autoimmune disease e.g. HIV Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients of the investigational products Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure) Alterations of coagulation (thrombocytes <150000 /mm3), PT < 50%, PTT > 40 sec Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study Renal insufficiency with serum creatinine > 1.4 mg/dL (>124 µmol/L) Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (> 43 µmol/L) Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.85 mmol/L),

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lipid emulsion with n-3 FA<br> | Drug: MLF 541<br>* 22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour<br>|
| Active Comparator: lipid emulsion without n-3 FA<br> | Drug: Lipofundin MCT<br>* 22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of pro inflammatory activity |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post OP