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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02976155
Enrollment
439
Registered
2016-11-29
Start date
2016-10-31
Completion date
2017-03-31
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill

Keywords

critically ill, intensive care, enteral nutrition

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.

Interventions

OTHERA 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).

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Before-after study model

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition7 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 nutrition7 days after ICU admission
The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition7 days after ICU admission

Secondary

MeasureTime frame
ICU mortality.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
Hospital mortality.From date of the ICU admission until discharge form hospital,assessed up to 12 months
ICU length of stayFrom 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026