Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

Parenteral Nutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176695
• Other study ID #: HC-G-H-0802
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2010
• Last updated: January 9, 2012
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2012
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

Drug:
• fish oil containing lipid emulsion
medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides
• MCT/LCT containing lipid emulsion
medium chain triglycerides, long chain triglycerides

Locations

Country	Name	City	State
China	Hospitals	Beijing
China	Nanjing Hospital	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate on the efficacy of fish oil on the nutrition status	Prealbumin as the primary endpoint variable	day 1 to day 6	No
Primary	To investigate on the efficacy of fish oil on an inflammatory parameter	LTB5/LTB4 as a second primary endpoint	day 1 to day 6	No
Secondary	Incidence of postoperative complications		6 days	Yes
Secondary	Liver function		6 days	Yes
Secondary	Coagulation parameters		6 days	Yes
Secondary	Blood chemistry		6 days	Yes
Secondary	SIRS		6 days	Yes