Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04274322 |
Recruitment Status : Unknown
Verified April 2020 by Qinggang GE, Peking University Third Hospital.
Recruitment status was: Active, not recruiting
First Posted : February 18, 2020
Last Update Posted : April 8, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Critically Ill Coronavirus Infections | Other: Nutrition support |
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 Type : | Observational |
Actual Enrollment : | 117 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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) |
Actual Study Start Date : | February 19, 2020 |
Actual Primary Completion Date : | April 4, 2020 |
Estimated Study Completion Date : | July 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Cohort 1
High NUTRIC score
|
Other: Nutrition support
Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement |
Cohort 2
low NUTRIC score
|
Other: Nutrition support
Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement |
- 28-day all cause mortality [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274322
China | |
Peking University Third Hospital | |
Beijing, China |
Responsible Party: | Qinggang GE, M.D. Chief physician, Peking University Third Hospital |
ClinicalTrials.gov Identifier: | NCT04274322 |
Other Study ID Numbers: |
COV_NUTRIC |
First Posted: | February 18, 2020 Key Record Dates |
Last Update Posted: | April 8, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Critically Ill Coronavirus Infections Nutritional Risk Nutrition Intensive Care Unit |
Coronavirus Infections Critical Illness Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Virus Diseases Disease Attributes Pathologic Processes |