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
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