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

Phase 3

Completed

• Conditions: GI Cancer
• Interventions: Drug: MLF 541; Drug: Lipofundin MCT

• Registration Number: NCT00798447
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lipid emulsion with n-3 FA	MLF 541	-
lipid emulsion without n-3 FA	Lipofundin MCT	-

Primary Outcome Measures

Name	Time	Method
reduction of pro inflammatory activity	30 days

Trial Locations

Locations (2)

National Taiwan University Hospital Taipei; 🇨🇳 Taipei, Taiwan

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan