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

NCT00798447 | Completed Phase 3

• 1 other identifier: HC-G-H-0603
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

GI Cancer

Keywords

post OP

Outcome Measures

Primary Outcomes (1)

• reduction of pro inflammatory activity

  30 days

Study Arms (2)

lipid emulsion with n-3 FA

EXPERIMENTAL

Drug: MLF 541

lipid emulsion without n-3 FA

ACTIVE COMPARATOR

Drug: Lipofundin MCT

Interventions

MLF 541 DRUG

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

lipid emulsion with n-3 FA

Lipofundin MCT DRUG

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

lipid emulsion without n-3 FA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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),

Sponsors & Collaborators

• B. Braun Melsungen AG: lead
• B.Braun Taiwan Co., Ltd.: collaborator

Study Sites (2)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

National Taiwan University Hospital Taipei

Taipei, Taiwan

Location

Related Publications (1)

• Ma CJ, Wu JM, Tsai HL, Huang CW, Lu CY, Sun LC, Shih YL, Chen CW, Chuang JF, Wu MH, Wang MY, Lin MT, Wang JY. Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients. Nutr J. 2015 Jan 21;14:9. doi: 10.1186/1475-2891-14-9.

  PMID: 25609264 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

TW (2)