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

Not Applicable

Suspended

• Conditions: Critical Illness
• Interventions: Other: intensive enteral nutrition; Other: routine enteral nutrition

• Registration Number: NCT02897713
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2016-11
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-23
• Last Update Posted: 2020-05-27
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intensive EN	intensive enteral nutrition	Intensive enteral nutrition is to performed until discharge with max during of 7 days
routine EN	routine enteral nutrition	Routine enteral nutrition is to performed until discharge with max during of 7 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, China