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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Other: intensive enteral nutrition
* Other: routine enteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive EN<br>Intensive enteral nutrition is to performed until discharge with max during of 7 days | Other: intensive enteral nutrition<br>* 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.<br>|
| Active Comparator: routine EN<br>Routine enteral nutrition is to performed until discharge with max during of 7 days | Other: routine enteral nutrition<br>* Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, enteral nutrition, feeding intolerance