Cholestasis Reversal: Efficacy of IV Fish Oil
NCT00910104
Bile Duct Diseases, Biliary Tract Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT03442361
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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All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: Day 3 to 16 after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: By 30 days after PN initiation
Difference between Intralipid and Clinoleic groups
Time frame: During PN Period
Difference between Intralipid and Clinoleic groups
Time frame: During PN Period
Difference between Intralipid and Clinoleic groups
University of Calgary
Other
Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Biochemistry and Clinical Outcomes
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