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

2018年2月15日 更新者: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.

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

206

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Intralipid
Standard soybean oil-based therapy
Clinoleic
Olive oil based therapy

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Serum ALP Level
大体时间:8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation

次要结果测量

结果测量
措施说明
大体时间
Serum ALT
大体时间:8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum GGT
大体时间:8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum TB
大体时间:8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum BD
大体时间:8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
Serum TG
大体时间:8 to 16 days after PN initiation
Difference between Intralipid and Clinoleic groups
8 to 16 days after PN initiation
IVLE prescriptions dosing
大体时间:Day 3 to 16 after PN initiation
Difference between Intralipid and Clinoleic groups
Day 3 to 16 after PN initiation
All cause mortality
大体时间:By 30 days after PN initiation
Difference between Intralipid and Clinoleic groups
By 30 days after PN initiation
Length of hospital stay
大体时间:During PN Period
Difference between Intralipid and Clinoleic groups
During PN Period
Infectious complications incidence
大体时间:During PN Period
Difference between Intralipid and Clinoleic groups
During PN Period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Maitreyi Raman、University of Calgary

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年7月1日

初级完成 (实际的)

2015年6月30日

研究完成 (实际的)

2018年1月10日

研究注册日期

首次提交

2018年1月23日

首先提交符合 QC 标准的

2018年2月15日

首次发布 (实际的)

2018年2月22日

研究记录更新

最后更新发布 (实际的)

2018年2月22日

上次提交的符合 QC 标准的更新

2018年2月15日

最后验证

2018年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AJCN Raman

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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