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
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
Scientific
158#, Shangtang Road
Hangzhou
310014
China
| Phone | +86 (0)571 85893281 |
|---|---|
| zjpphicu@126.com |
Scientific
351#, Mingyue Street
Jinhua, Zhejiang
321000
China
| Phone | +86 (0)579 82553393 |
|---|---|
| zh_zhang1984@hotmail.com |
Study information
| Study design | Interventional non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effectiveness of nutritional support algorithm on outcomes for critically ill patients |
| Study objectives | We 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) studied | 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 |
| Primary outcome measure | 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 study start date | 03/05/2016 |
| Completion date | 18/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 350 |
| Key inclusion criteria | Critically ill patients expected to stay in ICU for more than 3 days |
| Key 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 |
| Date of first enrolment | 05/05/2016 |
| Date of final enrolment | 18/12/2016 |
Locations
Countries of recruitment
- China
Study participating centres
310000
China
China
Wuxing
Huzhou
Zhejiang
-
China
Shaoxing
Zhejiang
-
China
Yiwu
Zhejiang
-
China
NingBo
Zhejiang
-
China
Taizhou
Zhejiang
-
China
Quzhou 324000
Zhejiang
-
China
Zhejiang
-
China
Jinhua
Zhejiang
-
China
Sponsor information
Hospital/treatment centre
158#, Shangtang Road
Hangzhou
310014
China
"ROR" |
https://ror.org/03k14e164 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 18/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available 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.
