Critical IllnessNCT03216993
An Early Enteral Nutrition Protocol in Shanghai
A study testing Protocol care in people with Critical Illness and Enteral Feeding Intolerance, run by Ruijin Hospital at 1 site in China.
Trial summary
compare different enteral nutrition strategy in patients with mechanical ventilation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Enteral Feeding Intolerance
- What is being tested?
- Protocol care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Oct 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients
- Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation
- Expecting MV more than 72 hours
Who cannot join
- Pregnancy
- ICU stay < 72hr
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients
compare different enteral nutrition strategy in patients with mechanical ventilation
Read the detailed description
There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.
- Conditions
- Critical Illness, Enteral Feeding Intolerance
- Being tested
- Standard care, Protocol care
- Keywords
- feeding protocol
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
Protocol careOther
Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Other | Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units Receives: Other: Standard care |
| Protocol care | Experimental | Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied Receives: Other: Protocol care |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy target fulfilling rate
the proportion of patients in both arms meeting the targeted energy in-take
Measured: 7 days from enrollment
protein target fulfilling rate
the proportion of patients in both arms meeting the targeted protein in-take
Measured: 7 days from enrollment
Secondary outcomes (1)
mortality
mortality
Measured: 28 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Dec 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erzhen Chen, Ruijin Hospital
- Investigators
- Zhen Er Chen, Doctor, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216993
- Sponsor's protocol ID
- Shanghai EEN
- Status last verified
- Apr 2018
- First submitted
- 8 Jul 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients
- ClinicalTrials.gov ID
- NCT03216993
- Acronym / sponsor ID
- Shanghai EEN
- Conditions
- Critical Illness, Enteral Feeding Intolerance
- Keywords
- feeding protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 13 Jul 2017 (actual)
- 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.
compare different enteral nutrition strategy in patients with mechanical ventilation
Detailed description
There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Other | Other: Standard careStandard care: patients receive enteral nutrition in accordance with the usual practice in the participating units |
| Protocol care | Experimental | Other: Protocol careProtocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICU patients
- Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation
- Expecting MV more than 72 hours
Key exclusion criteria (2 listed)
- Pregnancy
- ICU stay < 72hr
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 |
|---|---|---|
| Standard careStandard care: patients receive enteral nutrition in accordance with the usual practice in the participating units | Other | Standard care |
| Protocol careProtocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied | Other | Protocol care |
Primary outcome
energy target fulfilling rate
Time frame: 7 days from enrollment
the proportion of patients in both arms meeting the targeted energy in-take
protein target fulfilling rate
Time frame: 7 days from enrollment
the proportion of patients in both arms meeting the targeted protein in-take
1 secondary outcome
mortality
Time frame: 28 days from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Zhen Er Chen, Doctor study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol care in people with Critical Illness and Enteral Feeding Intolerance, run by Ruijin Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongping Qu, Doctor (+8618917762330, qhp10516@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy target fulfilling rate (time frame: 7 days from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2018.