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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00798447

Enrollment

100

Registered

2008-11-26

Start date

2008-11-30

Completion date

2010-10-31

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GI Cancer

Keywords

post OP

Brief summary

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

Interventions

DRUGMLF 541

22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour

DRUGLipofundin MCT

22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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),

Design outcomes

Primary

Measure	Time frame
reduction of pro inflammatory activity	30 days

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026