Clinical trial NCT02976155: 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
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Keywords: critically ill, intensive care, enteral nutrition
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Department of Emergency Medicine, People's Hospital of Shaoxing, Shaoxing, China.
name: Department of Emergency Medicine, Wenzhou Central Hospital, Wenzhou, China.
name: Department of Emergency Medicine, The First People's Hospital of Hangzhou, Hangzhou, China.
name: Department of Emergency Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
name: Sir Run Run Shaw Hospital
name: Emergency Department, The First People's Hospital of Huzhou, Huzhou, China.
name: Department of Critical Care Medicine, The First People's Hospital of Xiaoshan District, Hangzhou, China.
name: Emergency Department, Jinhua Hospital of Zhejiang University, Jinhua, China.
name: Department of Critical Care Medicine, The First People's Hospital of Fuyang district, Hangzhou, China.
name: Department of Critical Care Medicine, Beilun District People's Hospital, Ningbo, China.
name: Emergency Department, The Affiliated Hospital of Hangzhou Normal University, Hangzhou, China.
name: Department of Emergency Intensive Care Unit, Ruian people's Hospital, Ruian, China.
name: Yuyao People's Hospital
name: Department of Emergency Intensive Care Unit, The Second Hospital of Jiaxing, No 1518, Huanchengbei Rd, Jiaxing, China.
First posted: 2016-11-29
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before-after study model
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition
timeFrame: 7 days after ICU admission
measure: The time from hospital admission to the begain Enteral nutrition.
timeFrame: 7 days after ICU admission
measure: The time from hospital admission to achieve the target calorie.
timeFrame: 7 days after ICU admission
measure: The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition
timeFrame: 7 days after ICU admission
measure: The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition
timeFrame: 7 days after ICU admission
Secondary outcomes:
measure: ICU mortality.
timeFrame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
measure: Hospital mortality.
timeFrame: From date of the ICU admission until discharge form hospital,assessed up to 12 months
measure: ICU length of stay
timeFrame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
measure: Duration of mechanical ventilation.
timeFrame: From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months
measure: ICU fee.
timeFrame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
measure: The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)
timeFrame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang university, school of medicine.
state: Zhejiang
Study officials:
References:
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.