Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

NCT04051840 | Unknown Phase 1

• 1 other identifier: 2019-SR-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• biomarkers of liver functions

  Concentration of AST, ALT, TBIL, DBIL in the blood

  48 hours after operation.

Secondary Outcomes (3)

• markers of infection and inflammation

  48 hours after operation.

• Trenal function

  48 hours after operation.

• lipids and lipid upper derivatives

  48 hours after operation.

Study Arms (1)

ClinOleic group

EXPERIMENTAL

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)

Interventions

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

ClinOleic group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

RECRUITING

MeSH Terms

Interventions

ClinOleic

Central Study Contacts

Qiang Li, MD

CONTACT

+86 13505191133; liqiang020202@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 9, 2019
• Study Start: July 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-07

Locations

CN (1)