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

Parenteral Nutrition Associated Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442361
• Other study ID #: AJCN Raman
• Status: Completed
• Phase: N/A
• First received: January 23, 2018
• Last updated: February 15, 2018
• Start date: July 1, 2012
• Est. completion date: January 10, 2018

Study information

• Verified date: February 2018
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 10, 2018
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Liver Diseases
• Parenteral Nutrition Associated Liver Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum ALP Level	Difference between Intralipid and Clinoleic groups	8 to 16 days after PN initiation
Secondary	Serum ALT	Difference between Intralipid and Clinoleic groups	8 to 16 days after PN initiation
Secondary	Serum GGT	Difference between Intralipid and Clinoleic groups	8 to 16 days after PN initiation
Secondary	Serum TB	Difference between Intralipid and Clinoleic groups	8 to 16 days after PN initiation
Secondary	Serum BD	Difference between Intralipid and Clinoleic groups	8 to 16 days after PN initiation
Secondary	Serum TG	Difference between Intralipid and Clinoleic groups	8 to 16 days after PN initiation
Secondary	IVLE prescriptions dosing	Difference between Intralipid and Clinoleic groups	Day 3 to 16 after PN initiation
Secondary	All cause mortality	Difference between Intralipid and Clinoleic groups	By 30 days after PN initiation
Secondary	Length of hospital stay	Difference between Intralipid and Clinoleic groups	During PN Period
Secondary	Infectious complications incidence	Difference between Intralipid and Clinoleic groups	During PN Period