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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-10-31

Brief Summary

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

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Detailed Description

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Conditions

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GI Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lipid emulsion with n-3 FA

Group Type EXPERIMENTAL

MLF 541

Intervention Type DRUG

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

lipid emulsion without n-3 FA

Group Type ACTIVE_COMPARATOR

Lipofundin MCT

Intervention Type DRUG

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

Interventions

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MLF 541

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

Intervention Type DRUG

Lipofundin MCT

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

Intervention Type DRUG

Eligibility Criteria

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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),

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No