Critically IllNCT02976155
The Effect of Standardized Enteral Nutrition on Critically Ill Patients
A study testing A standard enteral nutrition protocol in people with Critically Ill, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- A standard enteral nutrition protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients who is expected the length of ICU stay for more than 3 days
Who cannot join
- Patients who can obtain enough calorie through independent oral feeding. Patients aged less than 18 years. Patients who are pregnant or breastfeeding. Patients who are burned. Patients with malignant tumor terminal stages of diseases
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang university, school of medicine.
Hangzhou, Zhejiang, 310009
About this study
Official title: The Effect of a Standard Enteral Nutrition Protocol on Critically Ill Patients: a Multiple-center, Prospective, Before-after Study
The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.
Read the detailed description
As investigators all know, the nutrition status in critically ill patients is associated with the prognosis of these patients. And it has been confirmed that early enteral nutrition results in better outcome. However,some epidemiological investigation reported that in most intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In 2007, a study reported that the percentage of early enteral nutrition within 48h is 64%, based on mechanical ventilated patients in 208 intensive care unit nationally. Other study indicated that the calorie supported by the enteral nutrition only constitute 50% of the target calorie. Several studies have showed that the application of a standard enteral nutrition protocol could result in an improvement in the delivery of enteral feedings to patients. However, there is no such study in China.The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.
- Conditions
- Critically Ill
- Being tested
- A standard enteral nutrition protocol
- Keywords
- critically ill, intensive care, enteral nutrition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A standard enteral nutrition protocolOther
Patients in the experimental arm, the practice of enteral nutrition will based on a standard protocol. The core content of this protocol includes five step：1. Whether the participants need nutrition therapy? 2. The choice of nutrition way? 3. Nasogastric tube or nasointestinal tube? 4. The choice of enteral nutrition type? 5. The target calorie and protein of the participants? And how to achieve these target？(In this study, the practice of the above protocol is the only intervention).
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | enteral nutrition according routine practice |
| Post-intervention | Experimental | The intervention in this arm is the application of a standard enteral nutrition protocol Receives: Other: A standard enteral nutrition protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition
Measured: 7 days after ICU admission
The time from hospital admission to the begain Enteral nutrition.
Measured: 7 days after ICU admission
The time from hospital admission to achieve the target calorie.
Measured: 7 days after ICU admission
The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition
Measured: 7 days after ICU admission
The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition
Measured: 7 days after ICU admission
Secondary outcomes (6)
ICU mortality.
Measured: From date of the ICU admission until discharge form ICU,assessed up to 12 months
Hospital mortality.
Measured: From date of the ICU admission until discharge form hospital,assessed up to 12 months
ICU length of stay
Measured: From date of the ICU admission until discharge form ICU,assessed up to 12 months
Duration of mechanical ventilation.
Measured: From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months
ICU fee.
Measured: From date of the ICU admission until discharge form ICU,assessed up to 12 months
The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)
Measured: From date of the ICU admission until discharge form ICU,assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before-after study model
- Masking
- None (open label)
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Emergency Medicine, People's Hospital of Shaoxing, Shaoxing, China., Department of Emergency Medicine, Wenzhou Central Hospital, Wenzhou, China., Department of Emergency Medicine, The First People's Hospital of Hangzhou, Hangzhou, China., Department of Emergency Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China., Sir Run Run Shaw Hospital, Emergency Department, The First People's Hospital of Huzhou, Huzhou, China., Department of Critical Care Medicine, The First People's Hospital of Xiaoshan District, Hangzhou, China., Emergency Department, Jinhua Hospital of Zhejiang University, Jinhua, China., Department of Critical Care Medicine, The First People's Hospital of Fuyang district, Hangzhou, China., Department of Critical Care Medicine, Beilun District People's Hospital, Ningbo, China., The Affiliated Hospital of Hangzhou Normal University, The Third Affiliated Hospital of Wenzhou Medical University, Yuyao People's Hospital, Department of Emergency Intensive Care Unit, The Second Hospital of Jiaxing, No 1518, Huanchengbei Rd, Jiaxing, China.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976155
- Sponsor's protocol ID
- 87783921
- Status last verified
- Sep 2018
- First submitted
- 15 Nov 2016
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jiang L, Huang X, Wu C, Tang J, Li Q, Feng X, He T, Wang Z, Gao J, Ruan Z, Hong W, Lai D, Zhao F, Huang Z, Lu Z, Tang W, Zhu L, Zhang B, Wang Z, Shen X, Lai J, Ji Z, Fu K, Hong Y, Dai J, Hong G, Xu W, Wang Y, Xie Y, Chen Y, Zhu X, Ding G, Gu L, Zhang M. The effects of an enteral nutrition feeding protocol on critically ill patients: A prospective multi-center, before-after study. J Crit Care. 2020 Apr;56:249-256. doi: 10.1016/j.jcrc.2020.01.018. Epub 2020 Jan 17.
PubMed 31986368
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Standard Enteral Nutrition Protocol on Critically Ill Patients: a Multiple-center, Prospective, Before-after Study
- ClinicalTrials.gov ID
- NCT02976155
- Acronym / sponsor ID
- 87783921
- Conditions
- Critically Ill
- Keywords
- critically ill, intensive care, enteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Department of Emergency Medicine, People's Hospital of Shaoxing, Shaoxing, China., Department of Emergency Medicine, Wenzhou Central Hospital, Wenzhou, China., Department of Emergency Medicine, The First People's Hospital of Hangzhou, Hangzhou, China., Department of Emergency Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China., Sir Run Run Shaw Hospital, Emergency Department, The First People's Hospital of Huzhou, Huzhou, China., Department of Critical Care Medicine, The First People's Hospital of Xiaoshan District, Hangzhou, China., Emergency Department, Jinhua Hospital of Zhejiang University, Jinhua, China., Department of Critical Care Medicine, The First People's Hospital of Fuyang district, Hangzhou, China., Department of Critical Care Medicine, Beilun District People's Hospital, Ningbo, China., The Affiliated Hospital of Hangzhou Normal University, The Third Affiliated Hospital of Wenzhou Medical University, Yuyao People's Hospital, Department of Emergency Intensive Care Unit, The Second Hospital of Jiaxing, No 1518, Huanchengbei Rd, Jiaxing, China.
- Study start
- Oct 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.
Detailed description
As investigators all know, the nutrition status in critically ill patients is associated with the prognosis of these patients. And it has been confirmed that early enteral nutrition results in better outcome. However,some epidemiological investigation reported that in most intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In 2007, a study reported that the percentage of early enteral nutrition within 48h is 64%, based on mechanical ventilated patients in 208 intensive care unit nationally. Other study indicated that the calorie supported by the enteral nutrition only constitute 50% of the target calorie. Several studies have showed that the application of a standard enteral nutrition protocol could result in an improvement in the delivery of enteral feedings to patients. However, there is no such study in China.The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before-after study model
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –enteral nutrition according routine practice |
| Post-intervention | Experimental | Other: A standard enteral nutrition protocolThe intervention in this arm is the application of a standard enteral nutrition protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill patients who is expected the length of ICU stay for more than 3 days
Key exclusion criteria (1 listed)
- Patients who can obtain enough calorie through independent oral feeding. Patients aged less than 18 years. Patients who are pregnant or breastfeeding. Patients who are burned. Patients with malignant tumor terminal stages of diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A standard enteral nutrition protocolPatients in the experimental arm, the practice of enteral nutrition will based on a standard protocol. The core content of this protocol includes five step：1. Whether the participants need nutrition therapy? 2. The choice of nutrition way? 3. Nasogastric tube or nasointestinal tube? 4. The choice of enteral nutrition type? 5. The target calorie and protein of the participants? And how to achieve these target？(In this study, the practice of the above protocol is the only intervention). | Other | Post-intervention |
Primary outcome
The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition
Time frame: 7 days after ICU admission
The time from hospital admission to the begain Enteral nutrition.
Time frame: 7 days after ICU admission
The time from hospital admission to achieve the target calorie.
Time frame: 7 days after ICU admission
The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition
Time frame: 7 days after ICU admission
The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition
Time frame: 7 days after ICU admission
6 secondary outcomes
ICU mortality.
Time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
Hospital mortality.
Time frame: From date of the ICU admission until discharge form hospital,assessed up to 12 months
ICU length of stay
Time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
Duration of mechanical ventilation.
Time frame: From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months
ICU fee.
Time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)
Time frame: From date of the ICU admission until discharge form ICU,assessed up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Derived from this study: PubMed 31986368Jiang L, Huang X, Wu C, Tang J, Li Q, Feng X, He T, Wang Z, Gao J, Ruan Z, Hong W, Lai D, Zhao F, Huang Z, Lu Z, Tang W, Zhu L, Zhang B, Wang Z, Shen X, Lai J, Ji Z, Fu K, Hong Y, Dai J, Hong G, Xu W, Wang Y, Xie Y, Chen Y, Zhu X, Ding G, Gu L, Zhang M. The effects of an enteral nutrition feeding protocol on critically ill patients: A prospective multi-center, before-after study. J Crit Care. 2020 Apr;56:249-256. doi: 10.1016/j.jcrc.2020.01.018. Epub 2020 Jan 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A standard enteral nutrition protocol in people with Critically Ill, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition (time frame: 7 days after ICU admission). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.