Clinical trial NCT01943409: Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils
Official title: Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstruction
Cancer
Ileus
Malnutrition
Surgery
Keywords: Parenteral nutrition
lipid emulsion
Intralipid
ClinOleic
Inflammation
Infection
Bloodstream Infection
length of stay
mortality
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prealbumin
timeFrame: at day 10
Secondary outcomes:
measure: Length of Stay
timeFrame: participants will be followed for the duration of hospital stay up to one year
measure: Mortality
timeFrame: participantes will be followed for the duration of hospital stay for up to 1 year
measure: Infections
timeFrame: until one week post-PN up to 1 year
measure: Change in Hand-grip Strength
timeFrame: at baseline (day 0) and day 10 of PN
measure: Change in Mid-arm Circumference
timeFrame: at baseline (day0) and day 10
measure: Subjective Global Assessment (SGA): Number Who Improved
timeFrame: at baseline (day 0) and day 10
measure: Change in High Sensitivity C-reactive Protein (Hs-CRP)
timeFrame: Baseline (day 0) and day 10
measure: Red Blood Cell Fatty Acid Composition: Linoleic
timeFrame: day 10
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Johane P Allard, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: