Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

NCT ID: NCT04051840

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-06-30

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 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.

Conditions

Nutritional Supplement Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ClinOleic (Baxter Healthcare, Deerfield, IL, USA)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Li, MD

Role: CONTACT

liqiang020202@163.com

+86 13505191133

Facility Contacts

Qiang Li

Role: primary

liqiang020202@163.com

+86 13505191133

Other Identifiers

2019-SR-101

Identifier Type: -

Identifier Source: org_study_id