An Early Enteral Nutrition Protocol in Shanghai

Critical Illness Clinical Trial

Official title:

The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03216993
• Other study ID #: Shanghai EEN
• Status: Not yet recruiting
• Phase: N/A
• First received: July 8, 2017
• Last updated: April 16, 2018
• Start date: December 1, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2018
• Source: Ruijin Hospital
• Contact: Hongping Qu, Doctor
• Phone: +8618917762330
• Email: qhp10516[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

compare different enteral nutrition strategy in patients with mechanical ventilation

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Enteral Feeding Intolerance

Intervention

Other:
• Standard care
Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
• Protocol care
Protocol care: patient receive enteral nutrition in accordance with enteral nutrition protocol studied

Locations

Country	Name	City	State
China	Ruijin	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy target fulfilling rate	the proportion of patients in both arms meeting the targeted energy in-take	7 days from enrollment
Primary	protein target fulfilling rate	the proportion of patients in both arms meeting the targeted protein in-take	7 days from enrollment
Secondary	mortality	mortality	28 days from enrollment