Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

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

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.

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.