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Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation

Primary Purpose

Critical Illness

Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intensive enteral nutrition
routine enteral nutrition
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring mechanical ventilation, enteral nutrition, feeding intolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • predicted time of mechanical ventilation more than 48 hours

Exclusion Criteria:

  • no enteral nutrition pathway
  • refuse to informal consent
  • surgeon refuse the protocol
  • palliative care

Sites / Locations

  • 180 Fenglin Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intensive EN

routine EN

Arm Description

Intensive enteral nutrition is to performed until discharge with max during of 7 days

Routine enteral nutrition is to performed until discharge with max during of 7 days

Outcomes

Primary Outcome Measures

Incidence rate of hospital-acquired infections
Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection

Secondary Outcome Measures

mortality of 28 days
ICU stay
free days of mechanical ventilation
rate of reaching 80% of energy target during 72 hours
EN-associated adverse events
rate of parenteral nutrition delivery

Full Information

First Posted
August 4, 2016
Last Updated
May 23, 2020
Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai 6th People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 10th People's Hospital, Shanghai Jinshan Hospital, Shanghai Minhang Central Hospital, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai East Hospital, Xuhui Central Hospital, Shanghai, Shanghai Tong Ren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02897713
Brief Title
Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation
Official Title
Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Suspended
Why Stopped
Similar study has been published.
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
Collaborators
Shanghai 6th People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 10th People's Hospital, Shanghai Jinshan Hospital, Shanghai Minhang Central Hospital, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai East Hospital, Xuhui Central Hospital, Shanghai, Shanghai Tong Ren Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
mechanical ventilation, enteral nutrition, feeding intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intensive EN
Arm Type
Experimental
Arm Description
Intensive enteral nutrition is to performed until discharge with max during of 7 days
Arm Title
routine EN
Arm Type
Active Comparator
Arm Description
Routine enteral nutrition is to performed until discharge with max during of 7 days
Intervention Type
Other
Intervention Name(s)
intensive enteral nutrition
Intervention Description
After recruitment, patients should be assessed for EN initiation during first 24 hours after ICU admission. 80% of energy target should be reached within 72 hours.
Intervention Type
Other
Intervention Name(s)
routine enteral nutrition
Intervention Description
Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.
Primary Outcome Measure Information:
Title
Incidence rate of hospital-acquired infections
Description
Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection
Time Frame
28 days after ICU admission
Secondary Outcome Measure Information:
Title
mortality of 28 days
Time Frame
28 days after ICU admission
Title
ICU stay
Time Frame
from ICU admission to timepoint of patient's discharge or death, up to 12 months
Title
free days of mechanical ventilation
Time Frame
during whole ICU stay, up to 12 months
Title
rate of reaching 80% of energy target during 72 hours
Time Frame
first 72 hours after ICU admission
Title
EN-associated adverse events
Time Frame
during whole ICU stay, up to 12 months
Title
rate of parenteral nutrition delivery
Time Frame
during whole ICU stay, up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: predicted time of mechanical ventilation more than 48 hours Exclusion Criteria: no enteral nutrition pathway refuse to informal consent surgeon refuse the protocol palliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duming Zhu, doctor
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
ZIP/Postal Code
20032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation

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