Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Chemistry and Clinical Outcomes

NCT03442361 | Completed

• 1 other identifier: AJCN Raman
• Study Type: observational
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Intravenous lipid emulsions (IVLE) are an essential component of parenteral nutrition (PN). Omega-6 reducing strategies may improve outcomes, including reduced PN associated liver disease. Objective: The primary objective was to compare serum alkaline phosphatase (ALP), among surgical and medical patients provided with either Intralipid or Clinoleic lipid emulsions. Design: In this quasi-experimental study the medical records of surgical and medical adult patients were reviewed from 3 Canadian hospitals that received PN with either soybean oil (Intralipid) or predominantly olive oil (Clinoleic) based lipid emulsions for at least 7 consecutive days.

Conditions

Parenteral Nutrition Associated Liver Disease

Outcome Measures

Primary Outcomes (1)

• Serum ALP Level

  Difference between Intralipid and Clinoleic groups

  8 to 16 days after PN initiation

Secondary Outcomes (9)

• Serum ALT

  8 to 16 days after PN initiation

• Serum GGT

  8 to 16 days after PN initiation

• Serum TB

  8 to 16 days after PN initiation

• Serum BD

  8 to 16 days after PN initiation

• Serum TG

  8 to 16 days after PN initiation

Study Arms (2)

Intralipid

Standard soybean oil-based therapy

Clinoleic

Olive oil based therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study patients included adult patients (\> 18 years) admitted to hospital who received PN with Intralipid or Clinoleic IVLEs for at least 7 consecutive days

You may qualify if:

• admitted to hospital who received PN with Intralipid or Clinoleic IVLEs for at least 7 consecutive days.

You may not qualify if:

• baseline liver disease
• home PN prior to admission
• ALP and total bilirubin (TB) not available within 3 days prior to PN start as well as between days 8 to 16 post PN start
• receipt of Diprivan 1%® (Propofol 116 - AstraZeneca Canada Inc., Mississauga, Canada) during PN support period
• enteral nutrition providing greater than 600 Kcal daily for longer than half of time period on PN
• oral intake of greater than 50% of hospital meal tray contents for longer than half of the PN support time period

Sponsors & Collaborators

• University of Calgary: lead

Study Officials

• Maitreyi Raman

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 22, 2018
• Study Start: July 1, 2012
• Primary Completion: June 30, 2015
• Study Completion: January 10, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share