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Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion

NCT03792087 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-08-02

No results posted yet for this study

Summary

The present protocol describes a randomized, open-labelled study in which either SmofKabiven Peripheral or a hospital compounded control Parenteral Nutrition (PN) regimen will be given to adult surgical patients for 5 consecutive days.

As serum prealbumin is a well-established surrogate efficacy parameter reflecting the patient´s nutritional status, the absolute change of the serum prealbumin level at the day of the final study visit compared to baseline will represent the primary efficacy parameter in the present study.

Conditions

  • Parenteral Feeding
  • Surgery

Interventions

DRUG

SmofKabiven Peripheral

Total Parenteral Nutrition

DRUG

Hospital compounded emulsion

Total Parenteral Nutrition

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Wu Guohao, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792087 on ClinicalTrials.gov