The Effect of Standardized Enteral Nutrition on Critically Ill Patients

NCT ID: NCT02976155

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

439 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Critically Ill

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Before-after study model
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-intervention

enteral nutrition according routine practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-intervention

The intervention in this arm is the application of a standard enteral nutrition protocol

Group Type EXPERIMENTAL

A standard enteral nutrition protocol

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Emergency Medicine, People's Hospital of Shaoxing, Shaoxing, China.

UNKNOWN

Sponsor Role collaborator

Department of Emergency Medicine, Wenzhou Central Hospital, Wenzhou, China.

UNKNOWN

Sponsor Role collaborator

Department of Emergency Medicine, The First People's Hospital of Hangzhou, Hangzhou, China.

UNKNOWN

Sponsor Role collaborator

Department of Emergency Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.

UNKNOWN

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Emergency Department, The First People's Hospital of Huzhou, Huzhou, China.

UNKNOWN

Sponsor Role collaborator

Department of Critical Care Medicine, The First People's Hospital of Xiaoshan District, Hangzhou, China.

UNKNOWN

Sponsor Role collaborator

Emergency Department, Jinhua Hospital of Zhejiang University, Jinhua, China.

UNKNOWN

Sponsor Role collaborator

Department of Critical Care Medicine, The First People's Hospital of Fuyang district, Hangzhou, China.

UNKNOWN

Sponsor Role collaborator

Department of Critical Care Medicine, Beilun District People's Hospital, Ningbo, China.

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Yuyao People's Hospital

OTHER

Sponsor Role collaborator

Department of Emergency Intensive Care Unit, The Second Hospital of Jiaxing, No 1518, Huanchengbei Rd, Jiaxing, China.

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The second affiliated hospital of Zhejiang university, school of medicine.

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 31986368 (View on PubMed)

Other Identifiers

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87783921

Identifier Type: -

Identifier Source: org_study_id

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