Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Sponsor

Johane Allard (Other)

Overall Status

Completed

CT.gov ID

NCT01943409

Collaborator

(none)

303

Enrollment

Location

Arms

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Obstruction Cancer Ileus Malnutrition Surgery	Drug: Intralipid Drug: ClinOleic	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

303 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Intralipid

Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital

Drug: Intralipid

soybean oil-based lipid emulsion

Experimental: 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.

Drug: ClinOleic

olive oil-based lipid emulsion

Outcome Measures

Primary Outcome Measures

Prealbumin [at baseline (day 0) and 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

Length of stay [participants will be followed for the duration of hospital stay, an expected average of 4 weeks]
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.
Mortality [participantes will be followed for the duration of hospital stay, an expected average of 4 weeks]
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.
Body mass index [Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks)]
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.
Infections [until one week post-PN (averag expected 4 weeks)]
we will record the infections the patients develop during PN until one week after PN
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
mid-arm circumference [at baseline (day0) and day 10]
This is a rough indicator of body fat
Subjective global assessment (SGA) [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
Antibiotic days [until one week post PN]
we will record antibiotic days from the start of PN until one week after PN is discontinued
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 [Baseline (day 0) and 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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