Critically IllNCT04274322
Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool
An observational study of Critically Ill and Coronavirus Infections, run by Peking University Third Hospital at 1 site in China.
Trial summary
There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Coronavirus Infections
- What is being tested?
- Nutrition support
- Type of treatment
- Pill or oral medicine
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2020to Jul 2020
- Phase
- Observational
- 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
Study population: The adult patients with 2019 coronavirus disease (COVID-19) admitted to ICU, Peking University Third Hopital from Feb 2020 to May 2020 will be involved in this study
Who may be able to join
- Admitted to intensive care unit (ICU), Peking University Third Hospital since Feb 2020
- Adult (aged over 18 years)
- Anticipate a length of ICU stay (LOS) of more than 48 hours
- Diagnosed as 2019 coronavirus disease (COVID-19)
- With food intake difficulties (can't intake food by oneself)
Who cannot join
- aged under 18 years
- Actual ICU LOS of less than 48 hours
- Using medications of IL-6 or IL-6R
- Overdose
- Written informed consent not obtained in the prospective cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool (COV_NUTRIC)
There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.
Read the detailed description
Heyland et al. previously proposed a novel scoring tool, the Nutrition Risk in Critically ill (NUTRIC) score, which is the first nutritional risk assessment tool developed and validated specifically for intensive care unit (ICU) patients. Many other risk scores and assessment tools exist to quantify nutrition risk but none have been specifically designed for ICU patients. Indeed, they generally consider all critically ill patients to be at high nutritional risk. However, the recognition that not all ICU patients will respond the same to nutritional interventions was the critical concept behind the NUTRIC score. There was an interaction between mortality, nutritional intake and NUTRIC score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. However, the inferences about the validity of the NUTRIC score are limited in Chinese patients because of no data.
The current outbreak of novel coronavirus was first reported from Wuhan, China on Dec ember 31 , 2019 . This virus was named as 2019 nCoV by World Health Organization ( on Jan uary 12 , 2020). Following the advice of the Emergency Committee, the WHO declared the outbreak of 2019 nCoV a Public Health Emergency of International Concern . Patients show fever and / or respiratory symptoms, with the imaging characteristics of pneumonia, and other symptoms include hemoptysis muscle pain, headache, confusion, chest pain, and diarrhea. About 16% patients need ICU admission.
The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19. This is a single-center, prospective cohort study of ICU patients with COVID-19. Data for all variables of the NUTRIC score will be collected. These include age, APACHE II score, SOFA score, number of co-morbidities, days from hospital admission to ICU admission. A logistic model including the NUTRIC score, the nutritional adequacy and their interaction will be estimated to assess if the NUTRIC score modified the association between nutritional adequacy and 28-day mortality.
- Conditions
- Critically Ill, Coronavirus Infections
- Being tested
- Nutrition support
- Keywords
- Critically Ill, Coronavirus Infections, Nutritional Risk, Nutrition, Intensive Care Unit
- Medical subject headings
- Critical Illness, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition supportOther
Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | High NUTRIC score Receives: Other: Nutrition support | |
| Cohort 2 | low NUTRIC score Receives: Other: Nutrition support |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all cause mortality
Measured: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Secondary outcomes (4)
All cause infection
Measured: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
The rate of complications
Measured: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Length of ICU stay
Measured: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Duration of mechanical ventilation
Measured: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start19 Feb 2020
- Primary completion4 Apr 2020
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- School of Pharmaceutical Sciences, Peking University, Beijing, China, Department of Medicine, Queen's University, Kingston, Ontario, Canada
- Responsible party
- Principal investigator, Qinggang GE, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274322
- Sponsor's protocol ID
- COV_NUTRIC
- Status last verified
- Apr 2020
- First submitted
- 16 Feb 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool (COV_NUTRIC)
- ClinicalTrials.gov ID
- NCT04274322
- Acronym / sponsor ID
- COV_NUTRIC
- Conditions
- Critically Ill, Coronavirus Infections
- Keywords
- Critically Ill, Coronavirus Infections, Nutritional Risk, Nutrition, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- School of Pharmaceutical Sciences, Peking University, Beijing, China, Department of Medicine, Queen's University, Kingston, Ontario, Canada
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 18 Feb 2020 (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.
There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.
Detailed description
Heyland et al. previously proposed a novel scoring tool, the Nutrition Risk in Critically ill (NUTRIC) score, which is the first nutritional risk assessment tool developed and validated specifically for intensive care unit (ICU) patients. Many other risk scores and assessment tools exist to quantify nutrition risk but none have been specifically designed for ICU patients. Indeed, they generally consider all critically ill patients to be at high nutritional risk. However, the recognition that not all ICU patients will respond the same to nutritional interventions was the critical concept behind the NUTRIC score. There was an interaction between mortality, nutritional intake and NUTRIC score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. However, the inferences about the validity of the NUTRIC score are limited in Chinese patients because of no data.
The current outbreak of novel coronavirus was first reported from Wuhan, China on Dec ember 31 , 2019 . This virus was named as 2019 nCoV by World Health Organization ( on Jan uary 12 , 2020). Following the advice of the Emergency Committee, the WHO declared the outbreak of 2019 nCoV a Public Health Emergency of International Concern . Patients show fever and / or respiratory symptoms, with the imaging characteristics of pneumonia, and other symptoms include hemoptysis muscle pain, headache, confusion, chest pain, and diarrhea. About 16% patients need ICU admission.
The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19. This is a single-center, prospective cohort study of ICU patients with COVID-19. Data for all variables of the NUTRIC score will be collected. These include age, APACHE II score, SOFA score, number of co-morbidities, days from hospital admission to ICU admission. A logistic model including the NUTRIC score, the nutritional adequacy and their interaction will be estimated to assess if the NUTRIC score modified the association between nutritional adequacy and 28-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Nutrition supportHigh NUTRIC score |
| Cohort 2 | – | Other: Nutrition supportlow NUTRIC score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The adult patients with 2019 coronavirus disease (COVID-19) admitted to ICU, Peking University Third Hopital from Feb 2020 to May 2020 will be involved in this study
Key inclusion criteria (5 listed)
- Admitted to intensive care unit (ICU), Peking University Third Hospital since Feb 2020
- Adult (aged over 18 years)
- Anticipate a length of ICU stay (LOS) of more than 48 hours
- Diagnosed as 2019 coronavirus disease (COVID-19)
- With food intake difficulties (can't intake food by oneself)
Key exclusion criteria (5 listed)
- aged under 18 years
- Actual ICU LOS of less than 48 hours
- Using medications of IL-6 or IL-6R
- Overdose
- Written informed consent not obtained in the prospective cohort
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 |
|---|---|---|
| Nutrition supportCalories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement | Other | Cohort 1, Cohort 2 |
Primary outcome
28-day all cause mortality
Time frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
4 secondary outcomes
All cause infection
Time frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
The rate of complications
Time frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Length of ICU stay
Time frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Duration of mechanical ventilation
Time frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
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?
An observational study of Critically Ill and Coronavirus Infections, run by Peking University Third 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 5 inclusion and 5 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 8 Apr 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?
28-day all cause mortality (time frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day). 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 8 Apr 2020.