The Effect of Standardized Enteral Nutrition on Critically Ill Patients

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976155
• Other study ID #: 87783921
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2018
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

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).

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang university, school of medicine.	Hangzhou	Zhejiang

Sponsors (15)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition		7 days after ICU admission
Primary	The time from hospital admission to the begain Enteral nutrition.		7 days after ICU admission
Primary	The time from hospital admission to achieve the target calorie.		7 days after ICU admission
Primary	The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition		7 days after ICU admission
Primary	The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition		7 days after ICU admission
Secondary	ICU mortality.		From date of the ICU admission until discharge form ICU,assessed up to 12 months
Secondary	Hospital mortality.		From date of the ICU admission until discharge form hospital,assessed up to 12 months
Secondary	ICU length of stay		From date of the ICU admission until discharge form ICU,assessed up to 12 months
Secondary	Duration of mechanical ventilation.		From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months
Secondary	ICU fee.		From date of the ICU admission until discharge form ICU,assessed up to 12 months
Secondary	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