Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/11/2017
Date assigned
24/11/2017
Last edited
07/08/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
There is a large body of evidence showing that enteral nutrition feeding (providing food or nutrition through a feeding tube) is of vital importance for the management of critically ill patients with multiple organ dysfunctions. Although there are many guidelines and protocols to improve the enteral feeding in critically ill patients, such protocols are not uniformly adopted in many Chinese hospitals, partly because the unawareness of the importance of enteral feeding protocol. Although many studies have reported improved outcome with standard enteral feeding protocol, others failed to identify benefits in patient-important outcomes such as mortality. The aim of this study is to explore the effectiveness of enteral feeding protocol in critically ill patients.

Who can participate?
Patients aged 18 and older who are expected to stay in the ICU for over three days.

What does the study involve?
Study participants are randomly allocated to one of two groups. Those in the first group receive the standardised feeding protocol. Participants are monitored closely for the occurance of gastrointestinal adverse events and enteral feeding is adjusted in stadardised way. Those in the second group receive the conventional enteral feeding protocol. They receive enteral feeding by the judgement of the treating physician and are not under the standardised protocol.

What are the possible benefits and risks of participating?
There are no direct benefits or risks for patients participating in the study. Conventional medical intervention will not be influenced by the study. The benefits and harms of the intervention are not known currently.

Where is the study run from?
Nanjing Central Hospital (China)

When is the study starting and how long is it expected to run for?
November 2017 to August 2019

Who is funding the study?
Nanjing Central Hospital (China)

Who is the main contact?
Dr Juan Xing

Trial website

Contact information

Type

Public

Primary contact

Dr Juan Xing

ORCID ID

Contact details

Nanjing Central Hospital
#305
Zhongshan East Road
Nanjing
210002
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2.0

Study information

Scientific title

Effectiveness of enteral feeding protocol on critically ill patients: a clustered randomized controlled trial

Acronym

Study hypothesis

The enteral feeding protocol is able to reduce nosocomial infection in critically ill patients.

Ethics approval

Ethics committee of Nanjing central hospital, 2017/11/18, ref: 22017NZKY-019-02

Study design

Clustered randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Critically ill patients

Intervention

Study participants are randomly allocated to one of two groups using cluster randomisation. Those in the first group receive the standardised feeding protocol. Participants are monitored closely for the occurrence of gastrointestinal adverse events and enteral feeding is adjusted in standardised way. The enteral feeding is standardized to accelerate the increment of enteral nutrition intake. The intervention is given for the whole ICU stay. Those in the second group receive the conventional enteral feeding protocol. They receive enteral feeding by the judgement of the treating physician and are not under the standardised protocol.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

28-day mortality is measured using the vital status at 28 days after enrollment.

Secondary outcome measures

1. Mechanical ventilation is measured using the duration of mechanical ventilation at 28 days
2. Nosocomial infection is measured using infection diagnosed 48 hours after enrollment
3. Proportion of enteral feeding is measured using the calorie of enteral nutrition intake at 3, 5 and 7 days

Overall trial start date

03/11/2017

Overall trial end date

31/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All patients expected to stay in ICU for over three days
2. Aged 18 and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2250

Participant exclusion criteria

1. Subjects receiving EN in previous 7 days
2. Contraindications for nasogastric or nasoenteric tube placement
3. Subjects who have already undergone percutaneous endoscopic jejunostomy (PEJ), percutaneous endoscopic gastrostomy (PEG) and surgical jejunostomy
4. Age younger than 18 years old
5. Women who are pregnant or undergo breast feeding
6. Burn patients

Recruitment start date

03/01/2018

Recruitment end date

31/05/2019

Locations

Countries of recruitment

China

Trial participating centre

Nanjing Central Hospital
Nanjing
210002
China

Sponsor information

Organisation

Nanjing Central Hospital

Sponsor details

#305
Zhongshan East road
Nanjing
210002
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Nanjing Central Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. Additional documents (such as study protocol, statistical analysis plan, other) will be available in Chinese version.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/05/2018 to 31/05/2019. 2. The overall trial end date was changed from 31/07/2018 to 31/08/2019. 3. The intention to publish date was changed from 03/12/2017 to 31/08/2019.