Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

Nanjing Medical University

Status and phase: Unknown; Phase 1

Conditions: Nutritional Supplement Toxicity

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04051840

2019-SR-101

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

ClinOleic group

Experimental group

Description:

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.

Treatment:

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