Nutritional Supplement Toxicity
Conditions
Brief summary
Small studies suggest differences in efficacy and safety exist between olive oil-based and soybean oil-based parenteral nutrition regimens in hospitalized adult patients. A study in China suggested that olive oil-based parenteral nutrition provided effective nutrition, was well tolerated, was associated with fewer infections and conferred greater ease-of-use than soybean oil-based parenteral nutrition. The objectives of this study were to assess safety and efficacy of an ClinOleic-based lipid parenteral nutrition regimen compared with Structolipid-based lipid parenteral nutrition regimen in Chinese adults after pancreatectomy for whom oral or enteral nutrition was not possible, insufficient or contraindicated.
Interventions
DRUGClinOleic (Baxter Healthcare, Deerfield, IL, USA)
ClinOleic group: Patients using ClinOleic or Structolipid-based lipid parenteral nutrition regimen. From day 0 to day 5, the goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid.
Sponsors
Baxter Healthcare Corporation
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* hospitalized ≤14 days before enrolment * required parenteral nutrition * had the capability to complete at least five days of study treatment; * useable peripheral vein for parenteral nutrition; * written informed consent.
Exclusion criteria
* A life expectancy of \<6 days; * hypersensitivity to the study treatments; * use of prohibited medications within 30 days before enrolment; * serious clinically significant condition such as congestive heart failure or severe renal insufficiency; * impaired hepatic function； * history of human immunodeficiency virus infection; * congenital abnormalities of amino acid metabolism; * severe dyslipidemia; * clinically significant abnormalities of plasma electrolytes; * currently pregnant or lactating; prior enrolment in this clinical trial; * participation in a clinical trial of any investigational drug or device concomitantly or within 30 days before enrolment in this clinical trial; * unsuitable in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| biomarkers of liver functions | 48 hours after operation. | Concentration of AST, ALT, TBIL, DBIL in the blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| markers of infection and inflammation | 48 hours after operation. | Concentration of CRP, PCT in the blood |
| Trenal function | 48 hours after operation. | Concentration of Crea, Urea in the blood |
| lipids and lipid upper derivatives | 48 hours after operation. | Concentration of arachidonic acid, eicosapentaenoic acid, linoleic acid, oleic acid in the blood |
Countries
China
Contacts
Primary ContactQiang Li, MD
Outcome results
None listed