NCT04713852

Brief Summary

The aim of this study is to evaluate the predictive value for in-hospital mortality of respectively the SOFA and Apache scores in a COVID-19 ICU cohort and to develop a new prediction model for COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

January 15, 2021

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    To predict the mortality based on the SOFA and Apache scores in critically ill ICU patients

    Patients admitted from 13th march 2020 to 17th october 2020

Secondary Outcomes (1)

  • Predictive value

    Patients admitted from 13th march 2020 to 17th october 2020

Eligibility Criteria

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

COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.

You may qualify if:

  • COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa hospital

Hasselt, 3500, Belgium

Location

Related Publications (1)

  • Vandenbrande J, Verbrugge L, Bruckers L, Geebelen L, Geerts E, Callebaut I, Gruyters I, Heremans L, Dubois J, Stessel B. Validation of the Acute Physiology and Chronic Health Evaluation (APACHE) II and IV Score in COVID-19 Patients. Crit Care Res Pract. 2021 Jun 19;2021:5443083. doi: 10.1155/2021/5443083. eCollection 2021.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 19, 2021

Study Start

March 13, 2020

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations