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

• Sponsor: University of Calgary (Other)
• Overall Status: Completed
• CT.gov ID: NCT03442361
• Collaborator: (none)
• Enrollment: 206
• Actual Duration (Months): 66.3

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

• 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: Jul 1, 2012
• Actual Primary Completion Date: Jun 30, 2015
• Actual Study Completion Date: Jan 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Intralipid Standard soybean oil-based therapy
Clinoleic Olive oil based therapy

Outcome Measures

Primary Outcome Measures

1. Serum ALP Level [8 to 16 days after PN initiation]

   Difference between Intralipid and Clinoleic groups

Secondary Outcome Measures

1. Serum ALT [8 to 16 days after PN initiation]

   Difference between Intralipid and Clinoleic groups

2. Serum GGT [8 to 16 days after PN initiation]

   Difference between Intralipid and Clinoleic groups

3. Serum TB [8 to 16 days after PN initiation]

   Difference between Intralipid and Clinoleic groups

4. Serum BD [8 to 16 days after PN initiation]

   Difference between Intralipid and Clinoleic groups

5. Serum TG [8 to 16 days after PN initiation]

   Difference between Intralipid and Clinoleic groups

6. IVLE prescriptions dosing [Day 3 to 16 after PN initiation]

   Difference between Intralipid and Clinoleic groups

7. All cause mortality [By 30 days after PN initiation]

   Difference between Intralipid and Clinoleic groups

8. Length of hospital stay [During PN Period]

   Difference between Intralipid and Clinoleic groups

9. Infectious complications incidence [During PN Period]

   Difference between Intralipid and Clinoleic groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Calgary

Investigators

• Principal Investigator: Maitreyi Raman, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maitreyi Raman, Principal Investigator, University of Calgary
• ClinicalTrials.gov Identifier: NCT03442361
• Other Study ID Numbers: AJCN Raman
• First Posted: Feb 22, 2018
• Last Update Posted: Feb 22, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Feb 22, 2018