Predictive Value of SOFA and APACHE Scores for In-hospital Mortality in COVID-19 ICU Patients

NCT ID: NCT04713852

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-13

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) emerged in December 2019 and has rapidly spread worldwide. The mortality of critical ill patients with COVID-19 has been reported variously as low as 11% and as high as 61%. The application of scoring systems can facilitate the effective evaluation by physicians to screen severe patients. At present, however, there are no specific scoring systems for the evaluation of COVID-19 patients. Scoring systems such as the Sequential Organ Failure Assessment (SOFA) score can help emergency or critical care physicians for prognosis and predicting mortality. The SOFA score described the condition of multiple organ dysfunction through several parameters, including oxygenation index, mean arterial pressure, Glasgow come scale, creatinine or urine volume, bilirubin, platelets for the respiratory, circulatory, neurological, renal, hepatogenic and coagulation systems respectively. The function of each organ system is scored from 0 to 4, and the individual SOFA scores are summed to a total score. Although SOFA was not initially designed to predict mortality, several studies reveal that SOFA could predict morbidity and mortality in severe ill patients.

Besides the SOFA score, the Acute Physiology and Chronic Health Evaluation (Apache II) scores was designed to measure the severity of disease of patients admitted to the ICU and to predict mortality. The Apache II score is calculated based on physiological measurements such as body temperature, mean arterial pressure, pH, heart and respiratory rate, Glasgow coma scale, oxygenation and blood parameters such as sodium, potassium, creatinine, hematocrit and white blood cell count. Recently, the Apache IV score is developed where additional parameters such as admission information, admission diagnosis and chronic health conditions were take into account.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stessel Björn

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jessa hospital

Hasselt, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34258059 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-174

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Factor Associated With Mortality in the ICU
NCT07249749 NOT_YET_RECRUITING