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

GI Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798447
• Other study ID #: HC-G-H-0603
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2008
• Last updated: June 8, 2011
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• GI Cancer

Intervention

Drug:
• MLF 541
22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
• Lipofundin MCT
22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital Taipei	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
B. Braun Melsungen AG	B.Braun Taiwan Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of pro inflammatory activity		30 days	No