Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

Conditions
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Cancer, Obstruction, Ileus, Malnutrition, Surgery

Intervention / Treatment
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* Drug: Intralipid
* Drug: ClinOleic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intralipid<br>Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital | Drug: Intralipid<br>* soybean oil-based lipid emulsion<br>|
| Experimental: ClinOleic<br>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. | Drug: ClinOleic<br>* olive oil-based lipid emulsion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prealbumin | 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. | at baseline (day 0) and day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay in the hospital and ICU will be recorded. We will record how many days it took,since admission to the hospital, for the patient to be discharged. This is an expected average of 4 weeks of length of stay. | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Mortality | We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable. The expected average of hospital stay is 4 weeks. | participantes will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Body mass index | We will measure weight before, at day 10 and after PN to calculate the BMI at this different points. The last day of PN is whenever the patient is taken off PN. This can vary considerably from patient to patient. | Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks) | 
| Infections | we will record the infections the patients develop during PN until one week after PN | until one week post-PN (averag expected 4 weeks) | 
| hand-grip strength | 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 | at baseline (day 0) and day 10 of PN | 
| mid-arm circumference | This is a rough indicator of body fat | at baseline (day0) and day 10 | 
| Subjective global assessment (SGA) | is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support | at baseline (day 0) and day 10 | 
| Antibiotic days | we will record antibiotic days from the start of PN until one week after PN is discontinued | until one week post PN | 
| high sensitivity C-reactive Protein (hs-CRP) | hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN | Baseline (day 0) and day 10 | 
| Red blood cell fatty acid composition | 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 | Baseline (day 0) and day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenteral nutrition, lipid emulsion, Intralipid, ClinOleic, Inflammation, Infection, Bloodstream Infection, length of stay, mortality