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

This study has been completed.
Sponsor:
Collaborator:
B.Braun Taiwan CO LTD
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT00798447
First received: November 25, 2008
Last updated: June 8, 2011
Last verified: June 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


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
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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),
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Taiwan
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
  More Information

No publications provided

Responsible Party: Study Manager, B.Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT00798447     History of Changes
Other Study ID Numbers: HC-G-H-0603
Study First Received: November 25, 2008
Last Updated: June 8, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by B. Braun Melsungen AG:
post OP

ClinicalTrials.gov processed this record on July 23, 2014