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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04274322
Collaborator
School of Pharmaceutical Sciences, Peking University, Beijing, China (Other), Department of Medicine, Queen's University, Kingston, Ontario, Canada (Other)
117
1
4.4
26.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

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 :
Feb 19, 2020
Actual Primary Completion Date :
Apr 4, 2020
Anticipated Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 28-day all cause mortality [from admission to 28-day/discharge, an average of length of ICU stay is 28-day]

Secondary Outcome Measures

  1. All cause infection [from admission to 28-day/discharge, an average of length of ICU stay is 28-day]

  2. The rate of complications [from admission to 28-day/discharge, an average of length of ICU stay is 28-day]

  3. Length of ICU stay [from admission to 28-day/discharge, an average of length of ICU stay is 28-day]

  4. Duration of mechanical ventilation [from admission to 28-day/discharge, an average of length of ICU stay is 28-day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qinggang GE, M.D. Chief physician, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04274322
Other Study ID Numbers:
  • COV_NUTRIC
First Posted:
Feb 18, 2020
Last Update Posted:
Apr 8, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qinggang GE, M.D. Chief physician, Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2020