NCT04274322

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

February 16, 2020

Last Update Submit

April 7, 2020

Conditions

Keywords

Critically IllCoronavirus InfectionsNutritional RiskNutritionIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 28-day all cause mortality

    from admission to 28-day/discharge, an average of length of ICU stay is 28-day

Secondary Outcomes (4)

  • 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

Study Arms (2)

Cohort 1

High NUTRIC score

Other: Nutrition support

Cohort 2

low NUTRIC score

Other: Nutrition support

Interventions

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

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Critical IllnessCoronavirus Infections

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Chief physician

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 18, 2020

Study Start

February 19, 2020

Primary Completion

April 4, 2020

Study Completion

July 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations