Back to resultsAn Early Enteral Nutrition Protocol in Shanghai
Primary Purpose
Critical Illness, Enteral Feeding Intolerance
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard care
Protocol care
Sponsored by
About this trial
This is an interventional other trial for Critical Illness focused on measuring feeding protocol
Eligibility Criteria
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
Sites / Locations
- Ruijin
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard care
Protocol care
Arm Description
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
Outcomes
Primary Outcome Measures
energy target fulfilling rate
the proportion of patients in both arms meeting the targeted energy in-take
protein target fulfilling rate
the proportion of patients in both arms meeting the targeted protein in-take
Secondary Outcome Measures
mortality
mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03216993
Brief Title
An Early Enteral Nutrition Protocol in Shanghai
Official Title
The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
compare different enteral nutrition strategy in patients with mechanical ventilation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Enteral Feeding Intolerance
Keywords
feeding protocol
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Other
Arm Description
Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Arm Title
Protocol care
Arm Type
Experimental
Arm Description
Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Intervention Type
Other
Intervention Name(s)
Protocol care
Intervention Description
Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied
Primary Outcome Measure Information:
Title
energy target fulfilling rate
Description
the proportion of patients in both arms meeting the targeted energy in-take
Time Frame
7 days from enrollment
Title
protein target fulfilling rate
Description
the proportion of patients in both arms meeting the targeted protein in-take
Time Frame
7 days from enrollment
Secondary Outcome Measure Information:
Title
mortality
Description
mortality
Time Frame
28 days from enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongping Qu, Doctor
Phone
+8618917762330
Email
qhp10516@rjh.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Zhong, Master
Phone
+8613564626325
Email
zm11716@rjh.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Er Chen, Doctor
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Early Enteral Nutrition Protocol in Shanghai
We'll reach out to this number within 24 hrs