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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

Tracking Information
First Submitted Date  ICMJE August 4, 2016
First Posted Date  ICMJE September 13, 2016
Last Update Posted Date May 27, 2020
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • mortality of 28 days [ Time Frame: 28 days after ICU admission ]
  • ICU stay [ Time Frame: from ICU admission to timepoint of patient's discharge or death, up to 12 months ]
  • free days of mechanical ventilation [ Time Frame: during whole ICU stay, up to 12 months ]
  • rate of reaching 80% of energy target during 72 hours [ Time Frame: first 72 hours after ICU admission ]
  • EN-associated adverse events [ Time Frame: during whole ICU stay, up to 12 months ]
  • rate of parenteral nutrition delivery [ Time Frame: during whole ICU stay, up to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation
Official Title  ICMJE Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Critical Illness
Intervention  ICMJE
  • 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.
  • Other: routine enteral nutrition
    Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.
Study Arms  ICMJE
  • Experimental: intensive EN
    Intensive enteral nutrition is to performed until discharge with max during of 7 days
    Intervention: Other: intensive enteral nutrition
  • Active Comparator: routine EN
    Routine enteral nutrition is to performed until discharge with max during of 7 days
    Intervention: Other: routine enteral nutrition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 7, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02897713
Other Study ID Numbers  ICMJE IEN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ming Zhong, Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE
  • 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  ICMJE
Study Chair: Duming Zhu, doctor Fudan University
PRS Account Shanghai Zhongshan Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP