Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation

Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial

Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.

Study Overview

• Status: Suspended
• Conditions: Critical Illness
• Intervention / Treatment: Other: intensive enteral nutrition; Other: routine enteral nutrition

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 20032
    • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• predicted time of mechanical ventilation more than 48 hours

Exclusion Criteria:

• no enteral nutrition pathway
• refuse to informal consent
• surgeon refuse the protocol
• palliative care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intensive EN; Intensive enteral nutrition is to performed until discharge with max during of 7 days	Other: intensive enteral nutrition; After recruitment, patients should be assessed for EN initiation during first 24 hours after ICU admission. 80% of energy target should be reached within 72 hours.
ACTIVE_COMPARATOR: routine EN; Routine enteral nutrition is to performed until discharge with max during of 7 days	Other: routine enteral nutrition; Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of hospital-acquired infections	Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection	28 days after ICU admission

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality of 28 days	28 days after ICU admission
ICU stay	from ICU admission to timepoint of patient's discharge or death, up to 12 months
free days of mechanical ventilation	during whole ICU stay, up to 12 months
rate of reaching 80% of energy target during 72 hours	first 72 hours after ICU admission
EN-associated adverse events	during whole ICU stay, up to 12 months
rate of parenteral nutrition delivery	during whole ICU stay, up to 12 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: RenJi Hospital; Shanghai 10th People's Hospital; Shanghai Tong Ren Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai East Hospital; Shanghai Tongji Hospital, Tongji University School of Medicine; Shanghai 6th People's Hospital; Shanghai Minhang Central Hospital; Xuhui Central Hospital, Shanghai; Shanghai Jinshan Hospital
• Investigators: Study Chair: Duming Zhu, doctor, Fudan University

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (ESTIMATE): September 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 23, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: mechanical ventilation; enteral nutrition; feeding intolerance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: IEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO