Recruitment

Recruitment Status
Completed
Estimated Enrollment
350

Inclusion Criterias

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

Exclusion Criterias

• Patients without PN during their hospitalization
• Patients without PN during their hospitalization

Summary

Conditions
  • Cancer
  • Ileus
  • Malnutrition
  • Obstruction
  • Surgery
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Inclusion Criterias

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

Exclusion Criterias

• Patients without PN during their hospitalization
• Patients without PN during their hospitalization

Locations

Toronto, Ontario, M5G 2C4
Toronto, Ontario, M5G 2C4

Tracking Information

NCT #
NCT01943409
Collaborators
Not Provided
Investigators
  • Principal Investigator: Johane P Allard, MD, FRCPC University Health Network, Toronto
  • Johane P Allard, MD, FRCPC University Health Network, Toronto