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

NCT ID: NCT02897713

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-06-30

Brief Summary

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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

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intensive EN

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

Group Type EXPERIMENTAL

intensive enteral nutrition

Intervention Type OTHER

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.

routine EN

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

Group Type ACTIVE_COMPARATOR

routine enteral nutrition

Intervention Type OTHER

Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.

Interventions

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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.

Intervention Type OTHER

routine enteral nutrition

Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai Jinshan Hospital

OTHER

Sponsor Role collaborator

Shanghai Minhang Central Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai East Hospital

OTHER

Sponsor Role collaborator

Xuhui Central Hospital, Shanghai

OTHER

Sponsor Role collaborator

Shanghai Tong Ren Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming Zhong

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duming Zhu, doctor

Role: STUDY_CHAIR

Fudan University

Locations

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180 Fenglin Road

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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IEN

Identifier Type: -

Identifier Source: org_study_id

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