The Effect of Standardized Enteral Nutrition on Critically Ill Patients

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT02976155

Collaborator

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

439

Enrollment

Location

Arms

Duration (Months)

88.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Critically Ill	Other: A standard enteral nutrition protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

439 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Before-after study modelBefore-after study model

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital of Zhejiang university, school of medicine.	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT02976155

Other Study ID Numbers:

87783921

First Posted:

Nov 29, 2016

Last Update Posted:

Jul 15, 2021

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

critically ill, intensive care, enteral nutrition

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Jul 15, 2021