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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02897713
Recruitment Status : Suspended (Similar study has been published.)
First Posted : September 13, 2016
Last Update Posted : May 27, 2020
Sponsor:
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
Information provided by (Responsible Party):
Ming Zhong, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Critical Illness Other: intensive enteral nutrition Other: routine enteral nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial
Study Start Date : November 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: intensive EN
Intensive enteral nutrition is to performed until discharge with max during of 7 days
Other: intensive enteral nutrition
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.

Active Comparator: routine EN
Routine enteral nutrition is to performed until discharge with max during of 7 days
Other: routine enteral nutrition
Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.




Primary Outcome Measures :
  1. Incidence rate of hospital-acquired infections [ Time Frame: 28 days after ICU admission ]
    Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection


Secondary Outcome Measures :
  1. mortality of 28 days [ Time Frame: 28 days after ICU admission ]
  2. ICU stay [ Time Frame: from ICU admission to timepoint of patient's discharge or death, up to 12 months ]
  3. free days of mechanical ventilation [ Time Frame: during whole ICU stay, up to 12 months ]
  4. rate of reaching 80% of energy target during 72 hours [ Time Frame: first 72 hours after ICU admission ]
  5. EN-associated adverse events [ Time Frame: during whole ICU stay, up to 12 months ]
  6. rate of parenteral nutrition delivery [ Time Frame: during whole ICU stay, up to 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897713


Locations
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China
180 Fenglin Road
Shanghai, China, 20032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
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
Investigators
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Study Chair: Duming Zhu, doctor Fudan University
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Responsible Party: Ming Zhong, associate professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02897713    
Other Study ID Numbers: IEN
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ming Zhong, Shanghai Zhongshan Hospital:
mechanical ventilation
enteral nutrition
feeding intolerance
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes