Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

NCT01176695 | Completed Phase 3

• 1 other identifier: HC-G-H-0802
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative parenteral nutrition.

Conditions

Parenteral Nutrition

Outcome Measures

Primary Outcomes (2)

• To investigate on the efficacy of fish oil on the nutrition status

  Prealbumin as the primary endpoint variable

  day 1 to day 6

• To investigate on the efficacy of fish oil on an inflammatory parameter

  LTB5/LTB4 as a second primary endpoint

  day 1 to day 6

Secondary Outcomes (5)

• Incidence of postoperative complications

  6 days

• Liver function

  6 days

• Coagulation parameters

  6 days

• Blood chemistry

  6 days

• SIRS

  6 days

Study Arms (2)

1

EXPERIMENTAL

fish oil containing lipid emulsion

Drug: fish oil containing lipid emulsion

2

ACTIVE COMPARATOR

MCT/LCT containing lipid emulsion

Drug: MCT/LCT containing lipid emulsion

Interventions

fish oil containing lipid emulsion DRUG

medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides

1

MCT/LCT containing lipid emulsion DRUG

medium chain triglycerides, long chain triglycerides

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery
• Male and female patients ≥18 and \<85 years of age
• Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation
• Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.

You may not qualify if:

• General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)
• General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency
• Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
• Other

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (2)

Hospitals

Beijing, 100730, China

Location

Nanjing Hospital

Nanjing, 210002, China

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ning Li, Prof. MD. PhD.

  Nanjing Hospital

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: August 6, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

CN (2)