Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442361
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Maitreyi Raman, 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.


Condition or disease
Parenteral Nutrition Associated Liver Disease

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Biochemistry and Clinical Outcomes
Actual Study Start Date : July 1, 2012
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : January 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
Drug Information available for: Olive oil

Group/Cohort
Intralipid
Standard soybean oil-based therapy
Clinoleic
Olive oil based therapy



Primary Outcome Measures :
  1. Serum ALP Level [ Time Frame: 8 to 16 days after PN initiation ]
    Difference between Intralipid and Clinoleic groups


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442361


Sponsors and Collaborators
University of Calgary
Investigators
Layout table for investigator information
Principal Investigator: Maitreyi Raman University of Calgary

Layout table for additonal information
Responsible Party: Maitreyi Raman, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT03442361     History of Changes
Other Study ID Numbers: AJCN Raman
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions