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

NCT02897713 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-05-27

No results posted yet for this study

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.

Conditions

  • Critical Illness

Interventions

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.

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    collaborator OTHER
  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER
  • Shanghai 10th People's Hospital

    collaborator OTHER
  • Shanghai Jinshan Hospital

    collaborator OTHER
  • Shanghai Minhang Central Hospital

    collaborator OTHER
  • RenJi Hospital

    collaborator OTHER
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Shanghai East Hospital

    collaborator OTHER
  • Xuhui Central Hospital, Shanghai

    collaborator OTHER
  • Shanghai Tong Ren Hospital

    collaborator OTHER
  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Duming Zhu, doctor · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897713 on ClinicalTrials.gov