Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

Study Overview
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Brief Summary
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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.

Official Title
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Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition After Pancreatectomy:a Prospective Study of Real World Clinical Research in China

Conditions
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Nutritional Supplement Toxicity

Intervention / Treatment
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* Drug: ClinOleic (Baxter Healthcare, Deerfield, IL, USA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ClinOleic group<br>Patients will be grouped to ClinOleic-based lipid parenteral nutrition regimen using ClinOleic or Structolipid-based lipid parenteral nutrition regimen using Structolipid. From day 0 to day 5, patients will not to receive any food or liquid oral or enteral nutrition. The goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid. The weight of patient calculated as ideal body weight. The patients will be allowed water based on the clinical judgment of the Investigator. From day 6 through the remainder of the study treatment period, liquid oral or enteral nutrition could be added to the study treatment. The intent is to supply the total calculated daily nutritional requirement with study treatment plus liquid oral or enteral nutrition. Liquid oral or enteral nutrition will be increased daily, as tolerated by the patient, with a concurrent reduction in study treatment, while still supplying the calculated daily nutritional requirement. | Drug: ClinOleic (Baxter Healthcare, Deerfield, IL, USA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarkers of liver functions | Concentration of AST, ALT, TBIL, DBIL in the blood | 48 hours after operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| markers of infection and inflammation | Concentration of CRP, PCT in the blood | 48 hours after operation. | 
| Trenal function | Concentration of Crea, Urea in the blood | 48 hours after operation. | 
| lipids and lipid upper derivatives | Concentration of arachidonic acid, eicosapentaenoic acid, linoleic acid, oleic acid in the blood | 48 hours after operation. |