Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Phase 4

Completed

Conditions: Obstruction
Cancer
Ileus
Malnutrition
Surgery

Interventions: Drug: Intralipid
Drug: ClinOleic

Registration Number: NCT01943409

Lead Sponsor: Johane Allard

Brief Summary: Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).

Detailed Description: Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.

There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.

The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 303

Inclusion Criteria

Patients 18 years or older
- Patients with PN during their hospitalization
- Patients hospitalized in medical, surgical or ICU wards
- Signed informed consent either from the patient, their legally authorized representative or a direct family member

Exclusion Criteria

• Patients without PN during their hospitalization

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralipid	Intralipid	Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
ClinOleic	ClinOleic	Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.

Primary Outcome Measures

Name	Time	Method
Prealbumin	at day 10	prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.

Secondary Outcome Measures

Name	Time	Method
Length of Stay	participants will be followed for the duration of hospital stay up to one year	Length of stay in the hospital and ICU will be recorded for 1 year
Mortality	participantes will be followed for the duration of hospital stay for up to 1 year	We will follow the patients from the day of admission until the day of discharge and record the mortality for 1 year
Infections	until one week post-PN up to 1 year	we will record the infections the patients develop during PN until one week after PN for 1 year
Change in Hand-grip Strength	at baseline (day 0) and day 10 of PN	We will measure hand grip strength at baseline (day0) and at day 10 of PN. This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength
Change in Mid-arm Circumference	at baseline (day0) and day 10	This is a rough indicator of body fat
Subjective Global Assessment (SGA): Number Who Improved	at baseline (day 0) and day 10	is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support
Change in High Sensitivity C-reactive Protein (Hs-CRP)	Baseline (day 0) and day 10	hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN
Red Blood Cell Fatty Acid Composition: Linoleic	day 10	Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency