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

Fudan University

Status: Suspended

Conditions: Critical Illness

Treatments: Other: routine enteral nutrition; Other: intensive enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT02897713

IEN

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

intensive EN

Experimental group

Description:

Intensive enteral nutrition is to performed until discharge with max during of 7 days

Treatment:

Other: intensive enteral nutrition

routine EN

Active Comparator group

Description:

Routine enteral nutrition is to performed until discharge with max during of 7 days

Treatment:

Other: routine enteral nutrition