An Early Enteral Nutrition Protocol in Shanghai

NCT ID: NCT03216993

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-10-01

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.

Conditions

Critical Illness; Enteral Feeding Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Standard care

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

Group Type: OTHER

Standard care

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Protocol care

Intervention Type: OTHER

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

Interventions

Standard care

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

Intervention Type: OTHER

Protocol care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erzhen Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen Er Chen, Doctor

Role: STUDY_CHAIR

Ruijin Hospital

Locations

Ruijin

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Hongping Qu, Doctor

Role: CONTACT

qhp10516@rjh.com.cn

+8618917762330

Ming Zhong, Master

Role: CONTACT

zm11716@rjh.com.cn

+8613564626325

Other Identifiers

Shanghai EEN

Identifier Type: -

Identifier Source: org_study_id