Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-chamber Parenteral Nutrition Formulation

Baxter

Status and phase: Completed; Phase 3

Conditions: Nutrition Support

Treatments: Other: Oliclinomel N4; Other: Compounded ternary parenteral nutrition admixtures

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579097

CSPIVTCHN001

Details and patient eligibility

About

The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.

Enrollment: 458 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatient but hospitalized < 14 days prior to enrollment
• Requires PN because oral or enteral nutrition is not possible, insufficient, or contraindicated
• Has capability to complete at least 5 days of study treatment (i.e., PN)
• Has a useable peripheral vein for delivery of intravenous (IV) PN

Exclusion criteria

• Has a life expectancy of < 6 days from initiation of study treatment, in the opinion of the Investigator
• Known hypersensitivity to the components of either of the investigational study treatments
• Use of prohibited medications (e.g. glucocorticosteroids or antitumor chemotherapeutic agents) within 30 days prior to enrollment
• Known serious clinically significant condition that would preclude participation in the study
• Known chronic active hepatitis, elevated liver function tests
• Known history of human immunodeficiency virus infection
• Known severe dyslipidemia, severe hyperglycemia,clinically significant abnormalities of plasma electrolytes
• Known pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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458 participants in 2 patient groups

compounded ternary parenteral nutrition

Active Comparator group

Description:

compounded ternary Parenteral Nutrition admixture

Treatment:

Other: Compounded ternary parenteral nutrition admixtures

Oliclinomel N4 formulation

Experimental group

Description:

Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag

Treatment:

Other: Oliclinomel N4