Parenteral Nutrition Associated Liver DiseaseNCT03442361
Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Chemistry and Clinical Outcomes
An observational study of Parenteral Nutrition Associated Liver Disease, run by University of Calgary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition Associated Liver Disease
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 10 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- admitted to hospital who received PN with Intralipid or Clinoleic IVLEs for at least 7 consecutive days.
Who cannot join
- 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
About this study
Official title: Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Biochemistry 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intralipid | Standard soybean oil-based therapy | |
| Clinoleic | Olive oil based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ALP Level
Difference between Intralipid and Clinoleic groups
Measured: 8 to 16 days after PN initiation
Secondary outcomes (9)
Serum ALT
Difference between Intralipid and Clinoleic groups
Measured: 8 to 16 days after PN initiation
Serum GGT
Difference between Intralipid and Clinoleic groups
Measured: 8 to 16 days after PN initiation
Serum TB
Difference between Intralipid and Clinoleic groups
Measured: 8 to 16 days after PN initiation
Serum BD
Difference between Intralipid and Clinoleic groups
Measured: 8 to 16 days after PN initiation
Serum TG
Difference between Intralipid and Clinoleic groups
Measured: 8 to 16 days after PN initiation
IVLE prescriptions dosing
Difference between Intralipid and Clinoleic groups
Measured: Day 3 to 16 after PN initiation
All cause mortality
Difference between Intralipid and Clinoleic groups
Measured: By 30 days after PN initiation
Length of hospital stay
Difference between Intralipid and Clinoleic groups
Measured: During PN Period
Infectious complications incidence
Difference between Intralipid and Clinoleic groups
Measured: During PN Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jul 2012
- Primary completion30 Jun 2015
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral Nutrition Associated Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maitreyi Raman, University of Calgary
- Investigators
- Maitreyi Raman, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442361
- Sponsor's protocol ID
- AJCN Raman
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Biochemistry and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03442361
- Acronym / sponsor ID
- AJCN Raman
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralipid | – | –Standard soybean oil-based therapy |
| Clinoleic | – | –Olive oil based therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- admitted to hospital who received PN with Intralipid or Clinoleic IVLEs for at least 7 consecutive days.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum ALP Level
Time frame: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
9 secondary outcomes
Serum ALT
Time frame: 8 to 16 days after PN initiation
Serum GGT
Time frame: 8 to 16 days after PN initiation
Serum TB
Time frame: 8 to 16 days after PN initiation
Serum BD
Time frame: 8 to 16 days after PN initiation
Serum TG
Time frame: 8 to 16 days after PN initiation
IVLE prescriptions dosing
Time frame: Day 3 to 16 after PN initiation
All cause mortality
Time frame: By 30 days after PN initiation
Length of hospital stay
Time frame: During PN Period
Infectious complications incidence
Time frame: During PN Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maitreyi Raman principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
An observational study of Parenteral Nutrition Associated Liver Disease, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum ALP Level (time frame: 8 to 16 days after PN initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.