Status:
COMPLETED
Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery
Lead Sponsor:
B. Braun Melsungen AG
Collaborating Sponsors:
B.Braun Taiwan Co., Ltd.
Conditions:
GI Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.
Eligibility Criteria
Inclusion
- 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
- 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),
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00798447
Start Date
November 1 2008
End Date
October 1 2010
Last Update
June 9 2011
Active Locations (2)
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1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
2
National Taiwan University Hospital Taipei
Taipei, Taiwan