An Early Enteral Nutrition Protocol in Shanghai

Not Applicable

• Conditions: Critical Illness; Enteral Feeding Intolerance
• Interventions: Other: Standard care; Other: Protocol care

• Registration Number: NCT03216993
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17
• Study Start: 2018-12-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Protocol care	Protocol care	Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied

Primary Outcome Measures

Name	Time	Method
energy target fulfilling rate	7 days from enrollment	the proportion of patients in both arms meeting the targeted energy in-take
protein target fulfilling rate	7 days from enrollment	the proportion of patients in both arms meeting the targeted protein in-take

Secondary Outcome Measures

Name	Time	Method
mortality	28 days from enrollment	mortality

Trial Locations

Locations (1)

Ruijin; 🇨🇳 Shanghai, Shanghai, China