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Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01176695
First received: May 10, 2010
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Parenteral Nutrition
 Drug: fish oil containing lipid emulsion
Drug: MCT/LCT containing lipid emulsion
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Controlled, Parallel Group, Multicenter Study on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion vs. a Medium and Long Chain Lipid Emulsion in Patients Undergoing Elective Abdominal Surgery of Moderate Severity

Resource links provided by NLM:

Drug Information available for: Fish oil
U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • To investigate on the efficacy of fish oil on the nutrition status [ Time Frame: day 1 to day 6 ] [ Designated as safety issue: No ]
    Prealbumin as the primary endpoint variable

  • To investigate on the efficacy of fish oil on an inflammatory parameter [ Time Frame: day 1 to day 6 ] [ Designated as safety issue: No ]
    LTB5/LTB4 as a second primary endpoint


Secondary Outcome Measures:
  • Incidence of postoperative complications [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Liver function [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Coagulation parameters [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Blood chemistry [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • SIRS [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
fish oil containing lipid emulsion
 Drug: fish oil containing lipid emulsion
medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides
Active Comparator: 2
MCT/LCT containing lipid emulsion
 Drug: MCT/LCT containing lipid emulsion
medium chain triglycerides, long chain triglycerides

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176695

Locations
China
Hospitals
Beijing, China, 100730
Nanjing Hospital
Nanjing, China, 210002
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Ning Li, Prof. MD. PhD. Nanjing Hospital
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01176695     History of Changes
Other Study ID Numbers: HC-G-H-0802
Study First Received: May 10, 2010
Last Updated: January 9, 2012
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013