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

Completed

• Conditions: Parenteral Nutrition Associated Liver Disease

• Registration Number: NCT03442361
• Lead Sponsor: University of Calgary

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.

Detailed Description

A few small studies have shown that a predominantly olive oil based IVLE is well tolerated and safe, however the clinical relevance of this IVLE is uncertain as no clear benefit in outcomes has been observed in small randomized clinical trials. Given the limited data available for the adult population reporting on the experience with olive oil based IVLE, we designed a quasi-experimental study to review our experience with Clinoleic compared to Intralipid. The primary objective was to compare the impact of Intralipid and Clinoleic IVLE on serum alkaline phosphatase (ALP), pre-PN to after one week of PN (i.e. between day 8 to 16 post-PN initiation), while controlling for the ordered lipid dosing. Secondary objectives were to assess if there were differences between the IVLEs on the remaining liver function tests, lipid dosing, incidence of infectious complications, length of stay in hospital and 30- day mortality.

This retrospective quasi-experimental chart review was conducted in 3 tertiary care hospitals in Calgary, AB between July 01, 2012 to June 30, 2013 and July 01, 2014 to June 30, 2015. Standard soybean oil-based therapy, Intralipid was the only available IVLE in Calgary, AB until July 2013, at which time predominantly olive oil Clinoleic was approved as an alternative in the hospital formulary, accounting for the dates chosen for the study. Ethics approval from the Conjoint Health Research and Ethics Board at the University of Calgary was obtained prior to the initiation of the study.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2015-06-30
• Study Completion: 2018-01-10
• Study First Submitted: 2018-01-23
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-15
• Last Update Submitted: 2018-02-15
• Study First Posted: 2018-02-22
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum ALP Level	8 to 16 days after PN initiation	Difference between Intralipid and Clinoleic groups

Secondary Outcome Measures

Name	Time	Method
Serum GGT	8 to 16 days after PN initiation	Difference between Intralipid and Clinoleic groups
Serum BD	8 to 16 days after PN initiation	Difference between Intralipid and Clinoleic groups
Serum ALT	8 to 16 days after PN initiation	Difference between Intralipid and Clinoleic groups
Serum TB	8 to 16 days after PN initiation	Difference between Intralipid and Clinoleic groups
Serum TG	8 to 16 days after PN initiation	Difference between Intralipid and Clinoleic groups
IVLE prescriptions dosing	Day 3 to 16 after PN initiation	Difference between Intralipid and Clinoleic groups
All cause mortality	By 30 days after PN initiation	Difference between Intralipid and Clinoleic groups
Infectious complications incidence	During PN Period	Difference between Intralipid and Clinoleic groups
Length of hospital stay	During PN Period	Difference between Intralipid and Clinoleic groups