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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infections; Critically Ill
• Intervention / Treatment: Other: Nutrition support

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 Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28-day all cause mortality	from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Secondary Outcome Measures

Outcome Measure	Time Frame
All cause infection	from admission to 28-day/discharge, an average of length of ICU stay is 28-day
The rate of complications	from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Length of ICU stay	from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Duration of mechanical ventilation	from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: School of Pharmaceutical Sciences, Peking University, Beijing, China; Department of Medicine, Queen's University, Kingston, Ontario, Canada

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2020
• Primary Completion (ACTUAL): April 4, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: February 16, 2020
• First Submitted That Met QC Criteria: February 16, 2020
• First Posted (ACTUAL): February 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus Infections; Nutrition; Intensive Care Unit; Critically Ill; Nutritional Risk
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Coronavirus Infections; Critical Illness
• Other Study ID Numbers: COV_NUTRIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No