NCT02897713

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

4.1 years

First QC Date

August 4, 2016

Last Update Submit

May 23, 2020

Conditions

Critical Illness

Keywords

mechanical ventilationenteral nutritionfeeding intolerance

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of hospital-acquired infections

    Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection

    28 days after ICU admission

Secondary Outcomes (6)

  • mortality of 28 days

    28 days after ICU admission

  • ICU stay

    from ICU admission to timepoint of patient's discharge or death, up to 12 months

  • free days of mechanical ventilation

    during whole ICU stay, up to 12 months

  • rate of reaching 80% of energy target during 72 hours

    first 72 hours after ICU admission

  • EN-associated adverse events

    during whole ICU stay, up to 12 months

  • +1 more secondary outcomes

Study Arms (2)

intensive EN

EXPERIMENTAL

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

Other: intensive enteral nutrition

routine EN

ACTIVE COMPARATOR

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

Other: routine enteral nutrition

Interventions

intensive enteral nutritionOTHER

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.

intensive EN
routine enteral nutritionOTHER

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

routine EN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • predicted time of mechanical ventilation more than 48 hours

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 20032, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Duming Zhu, doctor

    Fudan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 4, 2016

First Posted

September 13, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)