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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Intralipid
Standard soybean oil-based therapy
|
|
Clinoleic
Olive oil based therapy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum ALP Level
Tidsramme: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum ALT
Tidsramme: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum GGT
Tidsramme: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum TB
Tidsramme: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum BD
Tidsramme: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
Serum TG
Tidsramme: 8 to 16 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
8 to 16 days after PN initiation
|
|
IVLE prescriptions dosing
Tidsramme: Day 3 to 16 after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
Day 3 to 16 after PN initiation
|
|
All cause mortality
Tidsramme: By 30 days after PN initiation
|
Difference between Intralipid and Clinoleic groups
|
By 30 days after PN initiation
|
|
Length of hospital stay
Tidsramme: During PN Period
|
Difference between Intralipid and Clinoleic groups
|
During PN Period
|
|
Infectious complications incidence
Tidsramme: During PN Period
|
Difference between Intralipid and Clinoleic groups
|
During PN Period
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Maitreyi Raman, University of Calgary
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AJCN Raman
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