The Effect of Standardized Enteral Nutrition on Critically Ill Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Other: A standard enteral nutrition protocol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The second affiliated hospital of Zhejiang university, school of medicine.

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention; enteral nutrition according routine practice
Experimental: Post-intervention; The intervention in this arm is the application of a standard enteral nutrition protocol	Other: A standard enteral nutrition protocol; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Department of Emergency Medicine, People's Hospital of Shaoxing, Shaoxing, China.; Department of Emergency Medicine, Wenzhou Central Hospital, Wenzhou, China.; Department of Emergency Medicine, The First People's Hospital of Hangzhou, Hangzhou, China.; Department of Emergency Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.; Department of Emergency Medicine, Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.; Emergency Department, The First People's Hospital of Huzhou, Huzhou, China.; Department of Critical Care Medicine, The First People's Hospital of Xiaoshan District, Hangzhou, China.; Emergency Department, Jinhua Hospital of Zhejiang University, Jinhua, China.; Department of Critical Care Medicine, The First People's Hospital of Fuyang district, Hangzhou, China.; Department of Critical Care Medicine, Beilun District People's Hospital, Ningbo, China.; Emergency Department, The Affiliated Hospital of Hangzhou Normal University, Hangzhou, China.; Department of Emergency Intensive Care Unit, Ruian people's Hospital, Ruian, China.; Department of Emergency Medicine, Yuyao People's Hospital, Medical School of Ningbo University, Ningbo, China.; Department of Emergency Intensive Care Unit, The Second Hospital of Jiaxing, No 1518, Huanchengbei Rd, Jiaxing, China.

Publications and helpful links

General Publications

• Jiang L, Huang X, Wu C, Tang J, Li Q, Feng X, He T, Wang Z, Gao J, Ruan Z, Hong W, Lai D, Zhao F, Huang Z, Lu Z, Tang W, Zhu L, Zhang B, Wang Z, Shen X, Lai J, Ji Z, Fu K, Hong Y, Dai J, Hong G, Xu W, Wang Y, Xie Y, Chen Y, Zhu X, Ding G, Gu L, Zhang M. The effects of an enteral nutrition feeding protocol on critically ill patients: A prospective multi-center, before-after study. J Crit Care. 2020 Apr;56:249-256. doi: 10.1016/j.jcrc.2020.01.018. Epub 2020 Jan 17.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: critically ill, intensive care, enteral nutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 87783921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED