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
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
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