Critical IllnessNCT02897713
Feasibility, Safety, and Outcomes of Intensive Enteral Nutrition in Patients With Mechanical Ventilation
A study testing intensive enteral nutrition and routine enteral nutrition in people with Critical Illness, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- intensive enteral nutrition and routine enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- predicted time of mechanical ventilation more than 48 hours
Who cannot join
- no enteral nutrition pathway
- refuse to informal consent
- surgeon refuse the protocol
- palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial
Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.
- Conditions
- Critical Illness
- Being tested
- intensive enteral nutrition, routine enteral nutrition
- Keywords
- mechanical ventilation, enteral nutrition, feeding intolerance
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive enteral nutritionOther
After recruitment, patients should be assessed for EN initiation during first 24 hours after ICU admission. 80% of energy target should be reached within 72 hours.
routine enteral nutritionOther
Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.
| Study group | Role | What they receive |
|---|---|---|
| intensive EN | Experimental | Intensive enteral nutrition is to performed until discharge with max during of 7 days Receives: Other: intensive enteral nutrition |
| routine EN | Active comparator | Routine enteral nutrition is to performed until discharge with max during of 7 days Receives: Other: routine enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of hospital-acquired infections
Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection
Measured: 28 days after ICU admission
Secondary outcomes (6)
mortality of 28 days
Measured: 28 days after ICU admission
ICU stay
Measured: from ICU admission to timepoint of patient's discharge or death, up to 12 months
free days of mechanical ventilation
Measured: during whole ICU stay, up to 12 months
rate of reaching 80% of energy target during 72 hours
Measured: first 72 hours after ICU admission
EN-associated adverse events
Measured: during whole ICU stay, up to 12 months
rate of parenteral nutrition delivery
Measured: during whole ICU stay, 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 posted13 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Similar study has been published.
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 Shanghai Zhongshan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 10th People's Hospital, Shanghai Jinshan Hospital, Shanghai Minhang Central Hospital, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai East Hospital, Xuhui Central Hospital, Shanghai, Shanghai Tong Ren Hospital
- Responsible party
- Principal investigator, Ming Zhong, Shanghai Zhongshan Hospital
- Investigators
- Duming Zhu, doctor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897713
- Sponsor's protocol ID
- IEN
- Status last verified
- May 2020
- First submitted
- 4 Aug 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Outcomes of Intensive Enteral Nutrition in Mechanical-ventilated Patients: a Multicenter, Parallel Randomized Trial
- ClinicalTrials.gov ID
- NCT02897713
- Acronym / sponsor ID
- IEN
- Conditions
- Critical Illness
- Keywords
- mechanical ventilation, enteral nutrition, feeding intolerance
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Similar study has been published.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 10th People's Hospital, Shanghai Jinshan Hospital, Shanghai Minhang Central Hospital, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai East Hospital, Xuhui Central Hospital, Shanghai, Shanghai Tong Ren Hospital
- Study start
- Nov 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Sep 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.
Patients with mechanical ventilation are in risk of malnutrition, which could lead to worse outcome. According to guidelines released from authority organizations, enteral nutrition (EN) should be prior approach for critically ill patients. However, initiation and delivery of EN during the early period of ICU admission are frequently hampered, which results in underfeeding. The investigators speculate whether an intensive enteral nutrition strategy could reinforce the delivery of EN thereby improving outcomes. In this multi-center, prospective, randomized parallel clinical trial, the investigators aim to assess the feasibility, safety and outcomes of intensive enteral nutrition in mechanical-ventilated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive EN | Experimental | Other: intensive enteral nutritionIntensive enteral nutrition is to performed until discharge with max during of 7 days |
| routine EN | Active comparator | Other: routine enteral nutritionRoutine enteral nutrition is to performed until discharge with max during of 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- predicted time of mechanical ventilation more than 48 hours
Key exclusion criteria (4 listed)
- no enteral nutrition pathway
- refuse to informal consent
- surgeon refuse the protocol
- palliative care
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 |
|---|---|---|
| intensive enteral nutritionAfter recruitment, patients should be assessed for EN initiation during first 24 hours after ICU admission. 80% of energy target should be reached within 72 hours. | Other | intensive EN |
| routine enteral nutritionAttendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN. | Other | routine EN |
Primary outcome
Incidence rate of hospital-acquired infections
Time frame: 28 days after ICU admission
Hospital-acquired infections include ventilator-associated pneumonia, bloodstream infection, and urinary catheter-associated infection
6 secondary outcomes
mortality of 28 days
Time frame: 28 days after ICU admission
ICU stay
Time frame: from ICU admission to timepoint of patient's discharge or death, up to 12 months
free days of mechanical ventilation
Time frame: during whole ICU stay, up to 12 months
rate of reaching 80% of energy target during 72 hours
Time frame: first 72 hours after ICU admission
EN-associated adverse events
Time frame: during whole ICU stay, up to 12 months
rate of parenteral nutrition delivery
Time frame: during whole ICU stay, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- 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.
Duming Zhu, doctor study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive enteral nutrition and routine enteral nutrition in people with Critical Illness, run by Shanghai Zhongshan 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 1 inclusion and 4 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: paused, as of the sponsor's last update on 27 May 2020. 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?
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?
Incidence rate of hospital-acquired infections (time frame: 28 days after ICU admission). 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 27 May 2020.