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Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition

NCT03792100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2021-08-02

No results posted yet for this study

Summary

The present protocol describes a randomized, patient-blinded study in which either SmofKabiven emulsion for infusion or a hospital compounded "All in one" control Total Parenteral Nutrition (TPN) 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 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 Nutrition
  • Surgery

Interventions

DRUG

SmofKabiven emulsion for infusion

Total Parenteral Nutrition

DRUG

Hospital compounded "All in one" emulsion

Total Parenteral Nutrition

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Fresenius Kabi

    lead INDUSTRY

Principal Investigators

  • Zhang Zhongtao, MD · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2020-01-23
Completion
2020-01-23

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 NCT03792100 on ClinicalTrials.gov