An Early Enteral Nutrition Protocol in Shanghai

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03216993
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

compare different enteral nutrition strategy in patients with mechanical ventilation

Condition or Disease	Intervention/Treatment	Phase
Critical Illness; Enteral Feeding Intolerance	Other: Standard care; Other: Protocol care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients
• Anticipated Study Start Date: Dec 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard care Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units	Other: Standard care; Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Experimental: Protocol care Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied	Other: Protocol care; Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied

Outcome Measures

Primary Outcome Measures

1. energy target fulfilling rate [7 days from enrollment]

   the proportion of patients in both arms meeting the targeted energy in-take

2. protein target fulfilling rate [7 days from enrollment]

   the proportion of patients in both arms meeting the targeted protein in-take

Secondary Outcome Measures

1. mortality [28 days from enrollment]

   mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin	Shanghai	Shanghai	China	20000

Sponsors and Collaborators

• Ruijin Hospital

Investigators

• Study Chair: Zhen Er Chen, Doctor, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erzhen Chen, Professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT03216993
• Other Study ID Numbers: Shanghai EEN
• First Posted: Jul 13, 2017
• Last Update Posted: Apr 17, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Erzhen Chen, Professor, Ruijin Hospital: feeding protocol
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Apr 17, 2018