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Phase 4 N=303 Randomized Double-blind Supportive Care

Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Obstruction · Cancer · Ileus · Malnutrition · Surgery

Enrolled (actual)
303
Serious AEs
0.3%
Results posted
Feb 2025
Primary outcome: Primary: Prealbumin — 0.15; 0.16 g/l

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Intralipid (Drug); ClinOleic (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johane Allard
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Prealbumin
0.15; 0.16
SECONDARY
Length of Stay
45.63; 40.18
SECONDARY
Mortality
11; 13
SECONDARY
Infections
36; 40
SECONDARY
Change in Hand-grip Strength
0.10; -0.35
SECONDARY
Change in Mid-arm Circumference
-0.27; -0.18
SECONDARY
Subjective Global Assessment (SGA): Number Who Improved
12; 15
SECONDARY
Change in High Sensitivity C-reactive Protein (Hs-CRP)
-23.52; -29.42
SECONDARY
Red Blood Cell Fatty Acid Composition: Linoleic
578.34; 845.96

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).

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01943409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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