Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Chemistry and Clinical Outcomes
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Intralipid
Standard soybean oil-based therapy
|
|
Clinoleic
Olive oil based therapy
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Serum ALP Level
Ramy czasowe: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Serum ALT
Ramy czasowe: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum GGT
Ramy czasowe: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum TB
Ramy czasowe: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum BD
Ramy czasowe: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum TG
Ramy czasowe: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
IVLE prescriptions dosing
Ramy czasowe: Day 3 to 16 after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
Day 3 to 16 after PN initiation
|
|
All cause mortality
Ramy czasowe: By 30 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
By 30 days after PN initiation
|
|
Length of hospital stay
Ramy czasowe: During PN Period
|
Difference between Intralipid and Clinoleic groups
|
During PN Period
|
|
Infectious complications incidence
Ramy czasowe: During PN Period
|
Difference between Intralipid and Clinoleic groups
|
During PN Period
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Maitreyi Raman, University of Calgary
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AJCN Raman
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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