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

This study is not yet open for participant recruitment.

Verified by B. Braun Melsungen AG, November 2008

Sponsors and Collaborators:	B. Braun Melsungen AG B.Braun Taiwan CO LTD
Information provided by:	B. Braun Melsungen AG
ClinicalTrials.gov Identifier:	NCT00798447

Purpose

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

Condition	Intervention	Phase
GI Cancer	Drug: MLF 541 Drug: Lipofundin MCT	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Lipids

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:

reduction of pro inflammatory activity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
lipid emulsion with n-3 FA: Experimental	Drug: MLF 541 22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
lipid emulsion without n-3 FA: Active Comparator	Drug: Lipofundin MCT 22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour

Eligibility

Criteria

Inclusion Criteria:

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),

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798447

Contacts

Contact: Susanne Mientus, PhD

+49 5661 71 23 34

Locations

Taiwan
National Taiwan University Hospital Taipei
Taipei, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan

Sponsors and Collaborators

B. Braun Melsungen AG

B.Braun Taiwan CO LTD

More Information

Responsible Party:	B.Braun Melsungen AG ( Dr. Susanne Mientus )
Study ID Numbers:	HC-G-H-0603
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00798447
Health Authority:	Taiwan: Department of Health

Keywords provided by B. Braun Melsungen AG:

post OP

Study placed in the following topic categories:

Colorectal Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009