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

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ClinicalTrials.gov Identifier: NCT04274322
Recruitment Status : Active, not recruiting
First Posted : February 18, 2020
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
School of Pharmaceutical Sciences, Peking University, Beijing, China
Department of Medicine, Queen's University, Kingston, Ontario, Canada
Information provided by (Responsible Party):
Qinggang GE, Peking University Third Hospital

Study Description
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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
Critically Ill Coronavirus Infections 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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 28-day all cause mortality [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]

Secondary Outcome Measures :
  1. All cause infection [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
  2. The rate of complications [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
  3. Length of ICU stay [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]
  4. Duration of mechanical ventilation [ Time Frame: from admission to 28-day/discharge, an average of length of ICU stay is 28-day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China
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
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qinggang GE, Peking University Third Hospital:
Critically Ill
Coronavirus Infections
Nutritional Risk
Nutrition
Intensive Care Unit
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Critical Illness
Disease Attributes
Pathologic Processes
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases