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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ClinOleic group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClinOleic (Baxter Healthcare, Deerfield, IL, USA) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| biomarkers of liver functions | Concentration of AST, ALT, TBIL, DBIL in the blood | 48 hours after operation. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Li, MD | Contact | +86 13505191133 | liqiang020202@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | China |
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| ID | Term |
|---|---|
| C568346 | ClinOleic |
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| 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. |