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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00798447
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : June 9, 2011
B.Braun Taiwan Co., Ltd.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
GI Cancer Drug: MLF 541 Drug: Lipofundin MCT Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: lipid emulsion with n-3 FA Drug: MLF 541
22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour

Active Comparator: lipid emulsion without n-3 FA Drug: Lipofundin MCT
22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour

Primary Outcome Measures :
  1. reduction of pro inflammatory activity [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00798447

Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
National Taiwan University Hospital Taipei
Taipei, Taiwan
Sponsors and Collaborators
B. Braun Melsungen AG
B.Braun Taiwan Co., Ltd.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Manager, B.Braun Melsungen AG Identifier: NCT00798447     History of Changes
Other Study ID Numbers: HC-G-H-0603
First Posted: November 26, 2008    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by B. Braun Melsungen AG:
post OP