Status:
UNKNOWN
Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Nutritional Supplement Toxicity
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04051840
Start Date
July 1 2017
End Date
June 30 2020
Last Update
August 13 2019
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China