An Early Enteral Nutrition Protocol in Shanghai
The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients
1 other identifier
interventional
400
1 country
1
Brief Summary
compare different enteral nutrition strategy in patients with mechanical ventilation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedApril 17, 2018
April 1, 2018
2.1 years
July 8, 2017
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
energy target fulfilling rate
the proportion of patients in both arms meeting the targeted energy in-take
7 days from enrollment
protein target fulfilling rate
the proportion of patients in both arms meeting the targeted protein in-take
7 days from enrollment
Secondary Outcomes (1)
mortality
28 days from enrollment
Study Arms (2)
Standard care
OTHERStandard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Protocol care
EXPERIMENTALProtocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied
Interventions
Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied
Eligibility Criteria
You may qualify if:
- ICU patients
- Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation
- Expecting MV more than 72 hours
You may not qualify if:
- Pregnancy
- ICU stay \< 72hr
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin
Shanghai, Shanghai Municipality, 20000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhen Er Chen, Doctor
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 8, 2017
First Posted
July 13, 2017
Study Start
December 1, 2018
Primary Completion
December 31, 2020
Study Completion
October 1, 2021
Last Updated
April 17, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share