Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/11/2017
Date assigned
24/11/2017
Last edited
15/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Current plain English summary as of 15/01/2020:

Background and study aims
In the intensive care unit (ICU), nutritional therapy is one of the most crucial treatment for critically ill patients which may significantly influence the clinical outcomes. There is a large body of evidence showing that malnutrition is associated with significantly increased risk of death. Besides, ICU patients are at increased risk of underfeeding, which could further exacerbate the existing gap between energy demand and intake. The route of nutrition delivery is another important issue when starting nutritional therapy for ICU patients. Enteral feeding has been repeatedly proven to be superior over parenteral nutrition (PN) with respect to the clinical outcomes such as nosocomial infection and mortality.
China has one of the largest critically ill population in the world, and the clinical practice of EN feeding varies massively. Previous small studies have shown that the proportion of EN was as low as 40% on day 2, which could be improved with the implementation of EN feeding protocol.
However, to the best of our knowledge, there is a lack of large-scale data on the practice of enteral nutrition in ICUs. Cluster randomized method can effectively control the confounding factors between groups to obtain more reliable conclusions. In addition, patient-level
randomization would inevitably lead to pollution effect as the feeding protocol in the study group would always affect the clinical practice in the controls. Randomization at the hospital level and stratification could help avoid pollution.
Therefore, we conduct a multi-centered, cluster-randomized, parallel-controlled trial to assess the effect of a feeding protocol on nutritional therapy and clinical outcome in critically ill patients.

Who can participate?
Patients aged 18 and older who are expected to stay in the ICU for more than 7 days.

What does the study involve?
The R language will be used for randomization for this study. All the participating centers will be stratified according to the nature of its hospital (regional and tertiary) and ICU (emergency, medical, surgical, and general). Randomization will occur in a 1:1 fashion for the participating centers within the same category with computer-generated random numbers and all the randomization will be once completed. Allocation concealment was maintained by conducting randomization after consent to participate was obtained.
Arm#1 feeding protocol group: Implementation of enteral nutrition feeding protocol.
Arm#2 Control group: No adherence to uniform protocol and without any change to current clinical practice.

What are the possible benefits and risks of participating?
All patients will be cared for by the local treating team in each participating ICU, including monitor of vital signs, harvesting necessary blood samples for laboratory measurement, fluid therapy, and so on. As the feeding protocol used in this study has been tested in a pilot study without significant adverse effects, the application of this protocol should be largely safe. No specific monetary compensation available for each participant in this study.

Where is the study run from?
Jinling Hospital of Nanjing University (China)

When is the study starting and how long is it expected to run for?
December 2016 to December 2019

Who is funding the study?
Jinling Hospital of Nanjing University (China)

Who is the main contact?
Dr Lu Ke


_____
Previous 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 September 2019 (updated 17/06/2019, previously: August 2019)

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

Who is the main contact?
Dr Juan Xing

Trial website

https://capctg.medbit.cn/

Contact information

Type

Public

Primary contact

Dr Juan Xing

ORCID ID

Contact details

Nanjing Central Hospital
#305
Zhongshan East Road
Nanjing
210002
China

Type

Scientific

Additional contact

Dr Lu Ke

ORCID ID

http://orcid.org/0000-0001-8093-5073

Contact details

Jinling Hospital of Nanjing University
No.305 Zhongshan East Road
Nanjing
210002
China
+86-025-80861655
kkb9832@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2.0

Study information

Scientific title

EffectiveNess of feEding protocol on nutritional thErapy and clinical outcomes in critically ill patients: a multi-centered, cluster-ranDomized, parallel-controlled trial

Acronym

NEED

Study hypothesis

Current study hypothesis as of 15/01/2020:
A feeding protocol, compared to routine clinical practice, could reduce 28-day mortality in critically ill patients admitted to ICUs in China.

_____
Previous 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

Multi-centered, cluster-randomized, parallel-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

Current interventions as of 15/01/2020:

The R language will be used for randomization for this study. All the participating centers will be stratified according to the nature of its hospital (regional and tertiary) and ICU (emergency, medical, surgical, and general). Randomization will occur in a 1:1 fashion for the participating centers within the same category with computer-generated random numbers and all the randomization will be once completed. Allocation concealment was maintained by conducting randomization after consent to participate was obtained.

Arm#1 feeding protocol group: Implementation of enteral nutrition feeding protocol.
Arm#2 Control group: No adherence to uniform protocol and without any change to current clinical practice.

_____
Previous interventions:
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

Current primary outcome measure as of 15/01/2020:
All-cause mortality at day 28 after randomization (the day of randomization will be set as day 1)

_____
Previous primary outcome measure:
28-day mortality is measured using the vital status at 28 days after enrollment

Secondary outcome measures

Current secondary outcome measures as of 15/01/2020:

#Process measures
1. Time to start EN
2. Time to start PN
3. Mean nutrition support days within first 7 days after enrollment
3.1 Mean nutritional support (either EN or PN or both) days within first 7 days after enrollment
3.2 Mean EN support days within first 7 days after enrollment
3.3 Mean PN support days within first 7 days after enrollment
4. Target-reaching rate of EN on day3 and day7 after enrollment
5. EN tolerance score in first 7days after Enrollment
6. Days requiring prokinetic agents within first 7 days after enrollment
7. Proportion of patients receiving PN prescription with first 7 days after enrollment
8. Mean energy per day over first 7 days for patients who were fed
9. Proportion of patients never fed during the first 7 days after enrollment
10. Proportion of patients fed within 24 h after enrollment
11. Mean energy delivered for patients who were fed within first 7 days after enrollment
11.1 Mean energy delivered from EN within first 7 days after enrollment
11.2 Mean energy delivered from PN within first 7 days after enrollment
12. Proportion of patients who received a post-pyloric feeding tube (patients receiving EN) within first 7 days after enrollment.

#Organ dysfunction-related outcomes
1. New onset organ failure within first 7 days
1.1 New-onset respiratory failure;
1.2 New-onset cardiovascular failure;
1.3 New-onset renal failure
2. New receipt of organ support therapy within first 7 days
2.1 New receipt of mechanical ventilation (non-invasive included)
2.2 New receipt of renal replacement therapy
2.3 New receipt of vasoactive agents
2.4 Days requiring CRRT within first 7 days after enrollment
2.5 Days requiring insulin within first 7 days after enrollment
2.6 Days requiring MV within first 7 days after enrollment

#Additional outcomes
1. Incidence of secondary infection in ICU
2. Length of ICU stay

_____
Previous 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

26/12/2016

Overall trial end date

28/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 15/01/2020:
1. Informed consent form obtained from the patient or next of kin
2. 18 years or older
3. Within 24h of ICU admission
4. With one or more organ failure (SOFA for any single organ system≥2)
5. Expected to stay in ICU more than 7 days
6. Oral diet is not likely to be restored within three days

_____
Previous 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

Current exclusion criteria as of 15/01/2020:
1. Received EN in the past 3 days
2. Receiving palliative treatment or expected to die within 48 hours
3. Women in pregnancy
4. Long-term use of steroids or immunosuppressive agents
5. Patients with malignant diseases receiving radiotherapy or chemotherapy.

_____
Previous 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

26/03/2018

Recruitment end date

04/07/2019

Locations

Countries of recruitment

China

Trial participating centre

Nanjing Central Hospital
305 East Zhongshan Rd
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 at the trial website (added 15/01/2020).

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

30/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/01/2020: The following changes were made to the trial record: 1. The public title was changed from "To improve clinical outcomes of critically ill patients with enteral feeding protocol" to "Can a feeding protocol improve clinical outcomes in critically ill patients?". 2. The scientific title "Effectiveness of enteral feeding protocol on critically ill patients: a clustered randomized controlled trial" to "EffectiveNess of feEding protocol on nutritional thErapy and clinical outcomes in critically ill patients: a multi-centered, cluster-ranDomized, parallel-controlled trial". 3. The acronym was added. 4. The study hypothesis was changed. 5. The study design was changed from "Clustered randomised controlled trial" to "Multi-centered, cluster-randomized, parallel-controlled trial". 6. The overall start date was changed from 03/11/2017 to 26/12/2016. 7. The overall end date was changed from 30/09/2019 to 28/12/2019. 8. The interventions were changed. 9. The primary outcome measure was changed. 10. The secondary outcome measures were changed. 11. The trial website was added. 12. The inclusion criteria were changed. 13. The exclusion criteria were changed. 14. The recruitment start date was changed from 03/01/2018 to 26/03/2018. 15. The recruitment end date was changed from 30/06/2019 to 04/07/2019. 16. The plain English summary was updated. 17. The publication and dissemination plan was updated. 18. The intention to publish date was changed from 30/09/2020 to 30/12/2020. 17/06/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/05/2019 to 30/06/2019. 2. The overall end date was changed from 31/08/2019 to 30/09/2019. 3. The intention to publish date was changed from 31/08/2019 to 30/09/2020. 4. The plain English summary was updated to reflect these changes. 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.