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NCT Number: NCT03442361

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum ALP Level

    Time frame: 8 to 16 days after PN initiation

    Difference between Intralipid and Clinoleic groups

Secondary outcomes

  1. Serum ALT

    Time frame: 8 to 16 days after PN initiation

    Difference between Intralipid and Clinoleic groups

  2. Serum GGT

    Time frame: 8 to 16 days after PN initiation

    Difference between Intralipid and Clinoleic groups

  3. Serum TB

    Time frame: 8 to 16 days after PN initiation

    Difference between Intralipid and Clinoleic groups

  4. Serum BD

    Time frame: 8 to 16 days after PN initiation

    Difference between Intralipid and Clinoleic groups

  5. Serum TG

    Time frame: 8 to 16 days after PN initiation

    Difference between Intralipid and Clinoleic groups

  6. IVLE prescriptions dosing

    Time frame: Day 3 to 16 after PN initiation

    Difference between Intralipid and Clinoleic groups

  7. All cause mortality

    Time frame: By 30 days after PN initiation

    Difference between Intralipid and Clinoleic groups

  8. Length of hospital stay

    Time frame: During PN Period

    Difference between Intralipid and Clinoleic groups

  9. Infectious complications incidence

    Time frame: During PN Period

    Difference between Intralipid and Clinoleic groups

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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