Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

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

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.

Study Overview

• Status: Unknown
• Conditions: Nutritional Supplement Toxicity
• Intervention / Treatment: Drug: ClinOleic (Baxter Healthcare, Deerfield, IL, USA)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • the First Affiliated Hospital of Nanjing Medical University
    • Contact: Qiang Li; Phone Number: +86 13505191133; Email: liqiang020202@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ClinOleic group; Patients will be grouped to ClinOleic-based lipid parenteral nutrition regimen using ClinOleic or Structolipid-based lipid parenteral nutrition regimen using Structolipid. From day 0 to day 5, patients will not to receive any food or liquid oral or enteral nutrition. The goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid. The weight of patient calculated as ideal body weight. The patients will be allowed water based on the clinical judgment of the Investigator. From day 6 through the remainder of the study treatment period, liquid oral or enteral nutrition could be added to the study treatment. The intent is to supply the total calculated daily nutritional requirement with study treatment plus liquid oral or enteral nutrition. Liquid oral or enteral nutrition will be increased daily, as tolerated by the patient, with a concurrent reduction in study treatment, while still supplying the calculated daily nutritional requirement.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biomarkers of liver functions	Concentration of AST, ALT, TBIL, DBIL in the blood	48 hours after operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
markers of infection and inflammation	Concentration of CRP, PCT in the blood	48 hours after operation.
Trenal function	Concentration of Crea, Urea in the blood	48 hours after operation.
lipids and lipid upper derivatives	Concentration of arachidonic acid, eicosapentaenoic acid, linoleic acid, oleic acid in the blood	48 hours after operation.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-SR-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No