Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/04/2016
Date assigned
26/05/2016
Last edited
27/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Nutritional support is of vital importance for patients being treated in the intensive care unit (ICU) patients. These critically ill patients are at risk of not having adequate nutrition. Clinicians, for example, may delay enteral nutrition support due to the nature of the critical illness or after a patient has undergone major surgery. However, there is evidence that giving enteral nutrition early (that is, nutrition administered directly to the digestive system, for example into the stomach though a feeding tube) on is beneficial for a variety of reasons, such as reduced risk of developing ventilator associated pneumonia, protecting the enteral mucus (lining of the digestive system) and even a reduced risk of death while in hospital. However, it is not known at present how enteral nutrition support using a structured algorithm would benefit the critically ill. The study is designed to investigate this and provide evidence for using such a structured algorithm.

Who can participate?
Critically ill patients expected to stay in ICU for more than 3 days.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are provided enteral nutrition support via the structured algorithm. Those in group 2 (control) are not provided enteral nutrition support via the structured algorithm. All participants are followed up for the next 28 days, or until death, assessing them to see whether they develop ventilator associated pneumonia, for example, how long they require mechanical ventilation and the amount of nutrition they receive.

What are the possible benefits and risks of participating?
Participants in the intervention group may be more likely to receive adequate enteral nutrition earlier than they may otherwise have done.

Where is the study run from?
A total of ten hospitals in Zhejiang, China

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

Who is funding the study?
Zhejiang Provincial People's Hospital (China)

Who is the main contact?
1. Dr Renhua Sun (scientific)
zjpphicu@126.com
2. Dr Zhongheng Zhang (scientific)
zh_zhang1984@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Renhua Sun

ORCID ID

Contact details

158#
Shangtang Road
Hangzhou
310014
China
+86 (0)571 85893281
zjpphicu@126.com

Type

Scientific

Additional contact

Dr Zhongheng Zhang

ORCID ID

Contact details

351#
Mingyue Street
Jinhua
Zhejiang
321000
China
+86 (0)579 82553393
zh_zhang1984@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of nutritional support algorithm on outcomes for critically ill patients

Acronym

Study hypothesis

We hypothesized that the use of a enteral nutritional support algorithm would improve clinical outcomes for critically ill patients

Ethics approval

Ethics committee of Zhejiang Provincial People's Hospital, 27/04/2016, ref: 2016JS001

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Enteral feeding

Intervention

This study is evaluating an enteral nutritional support algorithm.

Critically ill patients are randomly allocated to one of two groups:
1. Those fed though the enteral nutritional support algorithm (intervention)
2. Those for which there is no protocol for enteral feeding (control)

The nutritional support algorithm is as follows:

1. Enteral feeding is considered when the subject is hemodynamically stable and fulfills the criteria
1.1. Mean arterial blood pressure > 65 mmHg
1.2. Serum lactate <4 mmil/l; and norepinephrine infusion rate <12.5 mcg/min

2. Then the gastrointestinal function is assessed and categorized as follows:
2.1. Normal function
2.2. Acute gastrointestinal injury grade 1-3
2.3. Contraindications for enteral feeding such as ischemic bowel disease, perforation, obstruction and AGI grade 3

Enteral feeding of 25 ml/hr is started for participants in category 2.1.
Enteral feeding at rate of 10-15 ml/hr is started for participants in category 2.2.
Total parenteral nutrition support is started for participants in category 2.3.

Patients are followed for 28 days after randomization or until death, depending on which occurs first. They are not followed up after conclusion of the study.

Intervention type

Other

Phase

Drug names

Primary outcome measures

28-day mortality

Secondary outcome measures

1. Incidence of ventilator associated pneumonia
2. Length of stay in ICU and hospital
3. Duration of mechanical ventilation
4. Biomarkers of nutritional status, including albumin, pre-albumin, chemistry profile, CD3, CD8, IgA, IgG, HLA-DR. They are measured via blood samples taken on a daily basis after enrollment into the study
5. Total amount of nutrition and the proportions of enteral and parenteral nutrition, measured by summing up calories intakes for the whole study period. Calories include enteral nutrition (commercial formula with fixed calorie per unit volume), and parenteral nutrition

Overall trial start date

03/05/2016

Overall trial end date

18/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Critically ill patients expected to stay in ICU for more than 3 days

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

1. Previous EN within 7 days of current episode of ICU admission
2. Burn patients
3. Pregnancy and breast feeding
4. Patients with PEJ, PEG

Recruitment start date

05/05/2016

Recruitment end date

18/12/2016

Locations

Countries of recruitment

China

Trial participating centre

Zhejiang Provincial People's Hospital
Zhejiang
310000
China

Trial participating centre

Zhejiang Provincial TCM Hospital
310000
China

Trial participating centre

Huzhou Central Hospital
198 Hongqi Rd Wuxing Huzhou
Zhejiang
-
China

Trial participating centre

Shaoxing People's Hospital
No.568, Zhongxing North Road Shaoxing
Zhejiang
-
China

Trial participating centre

YiWu Central Hospital
No.699,Jiangdong Road Yiwu
Zhejiang
-
China

Trial participating centre

NingBo First Hospital
No.59, LiuTing Street NingBo
Zhejiang
-
China

Trial participating centre

TaiZhou Hospital
No.150, Ximen Street Taizhou
Zhejiang
-
China

Trial participating centre

QuZhou People's Hospital
2 Zhouloudi Quzhou 324000
Zhejiang
-
China

Trial participating centre

LiShui People's Hospital
NO.15, LiShui City
Zhejiang
-
China

Trial participating centre

Jinhua Municipal Central Hospital
351#, Mingyue Street Jinhua
Zhejiang
-
China

Sponsor information

Organisation

Zhejiang Provincial People's Hospital

Sponsor details

158#
Shangtang Road
Hangzhou
310014
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Zhejiang Provincial People's Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

18/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27668228

Publication citations

Additional files

Editorial Notes

27/09/2016: Publication reference added.