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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04051840
Other study ID # 2019-SR-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 1, 2017
Est. completion date June 30, 2020

Study information

Verified date July 2019
Source The First Affiliated Hospital with Nanjing Medical University
Contact Qiang Li, MD
Phone +86 13505191133
Email liqiang020202@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 30, 2020
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ClinOleic (Baxter Healthcare, Deerfield, IL, USA)
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.

Locations

Country Name City State
China The First Affiliated Hospital of Nanjing Medical University Nanjing

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary biomarkers of liver functions Concentration of AST, ALT, TBIL, DBIL in the blood 48 hours after operation.
Secondary markers of infection and inflammation Concentration of CRP, PCT in the blood 48 hours after operation.
Secondary Trenal function Concentration of Crea, Urea in the blood 48 hours after operation.
Secondary lipids and lipid upper derivatives Concentration of arachidonic acid, eicosapentaenoic acid, linoleic acid, oleic acid in the blood 48 hours after operation.
See also
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