Back to resultsThe Effect of Standardized Enteral Nutrition on Critically Ill Patients
Primary Purpose
Critically Ill
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A standard enteral nutrition protocol
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill focused on measuring critically ill, intensive care, enteral nutrition
Eligibility Criteria
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
Sites / Locations
- The second affiliated hospital of Zhejiang university, school of medicine.
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Pre-intervention
Post-intervention
Arm Description
enteral nutrition according routine practice
The intervention in this arm is the application of a standard enteral nutrition protocol
Outcomes
Primary Outcome Measures
The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition
The time from hospital admission to the begain Enteral nutrition.
The time from hospital admission to achieve the target calorie.
The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition
The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition
Secondary Outcome Measures
ICU mortality.
Hospital mortality.
ICU length of stay
Duration of mechanical ventilation.
ICU fee.
The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)
Full Information
NCT ID
NCT02976155
First Posted
November 15, 2016
Last Updated
July 14, 2021
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.
1. Study Identification
Unique Protocol Identification Number
NCT02976155
Brief Title
The Effect of Standardized Enteral Nutrition on Critically Ill Patients
Official Title
The Effect of a Standard Enteral Nutrition Protocol on Critically Ill Patients: a Multiple-center, Prospective, Before-after Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
Keywords
critically ill, intensive care, enteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before-after study model
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
439 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-intervention
Arm Type
No Intervention
Arm Description
enteral nutrition according routine practice
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
The intervention in this arm is the application of a standard enteral nutrition protocol
Intervention Type
Other
Intervention Name(s)
A standard enteral nutrition protocol
Intervention Description
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).
Primary Outcome Measure Information:
Title
The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition
Time Frame
7 days after ICU admission
Title
The time from hospital admission to the begain Enteral nutrition.
Time Frame
7 days after ICU admission
Title
The time from hospital admission to achieve the target calorie.
Time Frame
7 days after ICU admission
Title
The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition
Time Frame
7 days after ICU admission
Title
The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition
Time Frame
7 days after ICU admission
Secondary Outcome Measure Information:
Title
ICU mortality.
Time Frame
From date of the ICU admission until discharge form ICU,assessed up to 12 months
Title
Hospital mortality.
Time Frame
From date of the ICU admission until discharge form hospital,assessed up to 12 months
Title
ICU length of stay
Time Frame
From date of the ICU admission until discharge form ICU,assessed up to 12 months
Title
Duration of mechanical ventilation.
Time Frame
From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months
Title
ICU fee.
Time Frame
From date of the ICU admission until discharge form ICU,assessed up to 12 months
Title
The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)
Time Frame
From date of the ICU admission until discharge form ICU,assessed up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The second affiliated hospital of Zhejiang university, school of medicine.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31986368
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Standardized Enteral Nutrition on Critically Ill Patients
We'll reach out to this number within 24 hrs