The Effect of Standardized Enteral Nutrition on Critically Ill Patients

Study Overview
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Brief Summary
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The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

Detailed Description
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As investigators all know, the nutrition status in critically ill patients is associated with the prognosis of these patients. And it has been confirmed that early enteral nutrition results in better outcome. However,some epidemiological investigation reported that in most intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In 2007, a study reported that the percentage of early enteral nutrition within 48h is 64%, based on mechanical ventilated patients in 208 intensive care unit nationally. Other study indicated that the calorie supported by the enteral nutrition only constitute 50% of the target calorie. Several studies have showed that the application of a standard enteral nutrition protocol could result in an improvement in the delivery of enteral feedings to patients. However, there is no such study in China.The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

Official Title
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The Effect of a Standard Enteral Nutrition Protocol on Critically Ill Patients: a Multiple-center, Prospective, Before-after Study

Conditions
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Critically Ill

Intervention / Treatment
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* Other: A standard enteral nutrition protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patients who is expected the length of ICU stay for more than 3 days Exclusion Criteria: Patients who can obtain enough calorie through independent oral feeding. Patients aged less than 18 years. Patients who are pregnant or breastfeeding. Patients who are burned. Patients with malignant tumor terminal stages of diseases

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: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Before-after study model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-intervention<br>enteral nutrition according routine practice | |
| Experimental: Post-intervention<br>The intervention in this arm is the application of a standard enteral nutrition protocol | Other: A standard enteral nutrition protocol<br>* Patients in the experimental arm, the practice of enteral nutrition will based on a standard protocol. The core content of this protocol includes five step：1. Whether the participants need nutrition therapy? 2. The choice of nutrition way? 3. Nasogastric tube or nasointestinal tube? 4. The choice of enteral nutrition type? 5. The target calorie and protein of the participants? And how to achieve these target？(In this study, the practice of the above protocol is the only intervention).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition |  | 7 days after ICU admission | 
| The time from hospital admission to the begain Enteral nutrition. |  | 7 days after ICU admission | 
| The time from hospital admission to achieve the target calorie. |  | 7 days after ICU admission | 
| The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition |  | 7 days after ICU admission | 
| The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition |  | 7 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality. |  | From date of the ICU admission until discharge form ICU,assessed up to 12 months | 
| Hospital mortality. |  | From date of the ICU admission until discharge form hospital,assessed up to 12 months | 
| ICU length of stay |  | From date of the ICU admission until discharge form ICU,assessed up to 12 months | 
| Duration of mechanical ventilation. |  | From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months | 
| ICU fee. |  | From date of the ICU admission until discharge form ICU,assessed up to 12 months | 
| The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.) |  | From date of the ICU admission until discharge form ICU,assessed up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critically ill, intensive care, enteral nutrition