Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool

NCT ID: NCT04274322

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 117 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2020-07-31

Brief 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. 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.

Conditions

Critically Ill; Coronavirus Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

High NUTRIC score

Nutrition support

Intervention Type: OTHER

Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement

Cohort 2

low NUTRIC score

Nutrition support

Intervention Type: OTHER

Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement

Interventions

Nutrition support

Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

School of Pharmaceutical Sciences, Peking University, Beijing, China

UNKNOWN

Sponsor Role: collaborator

Department of Medicine, Queen's University, Kingston, Ontario, Canada

UNKNOWN

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qinggang GE

M.D. Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Other Identifiers

COV_NUTRIC

Identifier Type: -

Identifier Source: org_study_id