Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

Nutritional Supplement Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04051840
• Other study ID #: 2019-SR-101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Nutritional Supplement Toxicity

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.