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Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

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ClinicalTrials.gov Identifier: NCT01176695
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To investigate on the efficacy of fish oil on the nutrition status [ Time Frame: day 1 to day 6 ]
    Prealbumin as the primary endpoint variable

  2. To investigate on the efficacy of fish oil on an inflammatory parameter [ Time Frame: day 1 to day 6 ]
    LTB5/LTB4 as a second primary endpoint


Secondary Outcome Measures :
  1. Incidence of postoperative complications [ Time Frame: 6 days ]
  2. Liver function [ Time Frame: 6 days ]
  3. Coagulation parameters [ Time Frame: 6 days ]
  4. Blood chemistry [ Time Frame: 6 days ]
  5. SIRS [ Time Frame: 6 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01176695     History of Changes
Other Study ID Numbers: HC-G-H-0802
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012