An Early Enteral Nutrition Protocol in Shanghai

April 16, 2018 updated by: Erzhen Chen, Ruijin Hospital

The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients

compare different enteral nutrition strategy in patients with mechanical ventilation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 20000
        • Ruijin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ICU patients
  • Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation
  • Expecting MV more than 72 hours

Exclusion Criteria:

  • Pregnancy
  • ICU stay < 72hr

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard care
Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Other: Standard care
Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Experimental: Protocol care
Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied
Other: Protocol care
Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
energy target fulfilling rate
Time Frame: 7 days from enrollment
the proportion of patients in both arms meeting the targeted energy in-take
7 days from enrollment
protein target fulfilling rate
Time Frame: 7 days from enrollment
the proportion of patients in both arms meeting the targeted protein in-take
7 days from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 28 days from enrollment
mortality
28 days from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: Zhen Er Chen, Doctor, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 8, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shanghai EEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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