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

B. Braun

Status and phase: Completed; Phase 3

Conditions: GI Cancer

Treatments: Drug: Lipofundin MCT; Drug: MLF 541

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798447

HC-G-H-0603

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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),

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

lipid emulsion with n-3 FA

Experimental group

Treatment:

Drug: MLF 541

lipid emulsion without n-3 FA

Active Comparator group

Treatment:

Drug: Lipofundin MCT