Nutritional support algorithm for critically ill patients

ISRCTN ISRCTN10583582
DOI https://doi.org/10.1186/ISRCTN10583582
Secondary identifying numbers N/A
Submission date
20/04/2016
Registration date
26/05/2016
Last edited
14/06/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Renhua Sun
Scientific

158#, Shangtang Road
Hangzhou
310014
China

Phone +86 (0)571 85893281
Email zjpphicu@126.com
Dr Zhongheng Zhang
Scientific

351#, Mingyue Street
Jinhua, Zhejiang
321000
China

Phone +86 (0)579 82553393
Email zh_zhang1984@hotmail.com

Study information

Study designInterventional non-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffectiveness of nutritional support algorithm on outcomes for critically ill patients
Study objectivesWe hypothesized that the use of a enteral nutritional support algorithm would improve clinical outcomes for critically ill patients
Ethics approval(s)Ethics committee of Zhejiang Provincial People's Hospital, 27/04/2016, ref: 2016JS001
Health condition(s) or problem(s) studiedEnteral feeding
InterventionThis 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 typeOther
Primary outcome measure28-day mortality
Secondary outcome measures1. 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 study start date03/05/2016
Completion date18/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants350
Key inclusion criteriaCritically ill patients expected to stay in ICU for more than 3 days
Key exclusion criteria1. Previous EN within 7 days of current episode of ICU admission
2. Burn patients
3. Pregnancy and breast feeding
4. Patients with PEJ, PEG
Date of first enrolment05/05/2016
Date of final enrolment18/12/2016

Locations

Countries of recruitment

  • China

Study participating centres

Zhejiang Provincial People's Hospital
Zhejiang
310000
China
Zhejiang Provincial TCM Hospital
310000
China
Huzhou Central Hospital
198 Hongqi Rd
Wuxing
Huzhou
Zhejiang
-
China
Shaoxing People's Hospital
No.568, Zhongxing North Road
Shaoxing
Zhejiang
-
China
YiWu Central Hospital
No.699,Jiangdong Road
Yiwu
Zhejiang
-
China
NingBo First Hospital
No.59, LiuTing Street
NingBo
Zhejiang
-
China
TaiZhou Hospital
No.150, Ximen Street
Taizhou
Zhejiang
-
China
QuZhou People's Hospital
2 Zhouloudi
Quzhou 324000
Zhejiang
-
China
LiShui People's Hospital
NO.15, LiShui City
Zhejiang
-
China
Jinhua Municipal Central Hospital
351#, Mingyue Street
Jinhua
Zhejiang
-
China

Sponsor information

Zhejiang Provincial People's Hospital
Hospital/treatment centre

158#, Shangtang Road
Hangzhou
310014
China

ROR logo "ROR" https://ror.org/03k14e164

Funders

Funder type

Hospital/treatment centre

Zhejiang Provincial People's Hospital

No information available

Results and Publications

Intention to publish date18/12/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/08/2016 Yes No
Results article results 03/08/2017 Yes No
Dataset 14/06/2023 No No

Editorial Notes

14/06/2023: Link to dataset added.
18/12/2017: Publication reference added.
27/09/2016: Publication reference added.