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

Critically Ill Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04274322
• Other study ID #: COV_NUTRIC
• Status: Active, not recruiting
• Start date: February 19, 2020
• Est. completion date: July 2020

Study information

• Verified date: April 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: July 2020
• Est. primary completion date: April 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Critical Illness
• Critically Ill
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Nutrition support
Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Department of Medicine, Queen's University, Kingston, Ontario, Canada, School of Pharmaceutical Sciences, Peking University, Beijing, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day all cause mortality		from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Secondary	All cause infection		from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Secondary	The rate of complications		from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Secondary	Length of ICU stay		from admission to 28-day/discharge, an average of length of ICU stay is 28-day
Secondary	Duration of mechanical ventilation		from admission to 28-day/discharge, an average of length of ICU stay is 28-day