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

15 februari 2018 uppdaterad av: Maitreyi Raman, University of Calgary

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

206

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Study patients included adult patients (> 18 years) admitted to hospital who received PN with Intralipid or Clinoleic IVLEs for at least 7 consecutive days

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intralipid
Standard soybean oil-based therapy
Clinoleic
Olive oil based therapy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serum ALP Level
Tidsram: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serum ALT
Tidsram: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum GGT
Tidsram: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum TB
Tidsram: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum BD
Tidsram: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum TG
Tidsram: 8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
IVLE prescriptions dosing
Tidsram: Day 3 to 16 after PN initiation
Difference between Intralipid and Clinoleic groups
Day 3 to 16 after PN initiation
All cause mortality
Tidsram: By 30 days after PN initiation
Difference between Intralipid and Clinoleic groups
By 30 days after PN initiation
Length of hospital stay
Tidsram: During PN Period
Difference between Intralipid and Clinoleic groups
During PN Period
Infectious complications incidence
Tidsram: During PN Period
Difference between Intralipid and Clinoleic groups
During PN Period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Calgary

Utredare

  • Huvudutredare: Maitreyi Raman, University of Calgary

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2012

Primärt slutförande (Faktisk)

30 juni 2015

Avslutad studie (Faktisk)

10 januari 2018

Studieregistreringsdatum

Först inskickad

23 januari 2018

Först inskickad som uppfyllde QC-kriterierna

15 februari 2018

Första postat (Faktisk)

22 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 februari 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AJCN Raman

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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