Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

• Status: Unknown status
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborator: Baxter Healthcare Corporation

Criteria

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.