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An Early Enteral Nutrition Protocol in Shanghai

The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03216993
Enrollment
400
Registered
2017-07-13
Start date
2018-12-01
Completion date
2021-10-01
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Enteral Feeding Intolerance

Keywords

feeding protocol

Brief summary

compare different enteral nutrition strategy in patients with mechanical ventilation

Detailed description

There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.

Interventions

OTHERStandard care

Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units

Protocol care: patient receive enteral nutrition in accordance with enteral nutrition protocol studied

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* ICU patients * Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation * Expecting MV more than 72 hours

Exclusion criteria

* Pregnancy * ICU stay \< 72hr

Design outcomes

Primary

MeasureTime frameDescription
energy target fulfilling rate7 days from enrollmentthe proportion of patients in both arms meeting the targeted energy in-take
protein target fulfilling rate7 days from enrollmentthe proportion of patients in both arms meeting the targeted protein in-take

Secondary

MeasureTime frameDescription
mortality28 days from enrollmentmortality

Countries

China

Contacts

Primary ContactHongping Qu, Doctor
qhp10516@rjh.com.cn+8618917762330
Backup ContactMing Zhong, Master
zm11716@rjh.com.cn+8613564626325

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026