Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

Last updated: August 11, 2019
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04051840
2019-SR-101
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 severerenal 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 concomitantlyor within 30 days before enrolment in this clinical trial;

  • unsuitable in the opinion of the Investigator.

Study Design

Total Participants: 200
Study Start date:
July 01, 2017
Estimated Completion Date:
June 30, 2020

Connect with a study center

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing,
    China

    Active - Recruiting

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