- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04713852
Predictive Value of SOFA and APACHE Scores for In-hospital Mortality in COVID-19 ICU Patients
Predictive Value of SOFA and APACHE Scores for In-hospital Mortality in COVID-19 ICU Patients: a Longitudinal Single-center Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hasselt, Belgium, 3500
- Jessa Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mortality
Time Frame: Patients admitted from 13th march 2020 to 17th october 2020
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To predict the mortality based on the SOFA and Apache scores in critically ill ICU patients
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Patients admitted from 13th march 2020 to 17th october 2020
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive value
Time Frame: Patients admitted from 13th march 2020 to 17th october 2020
|
Predictive value of DNR code, gender, BMI, hypertension, Diabetes, age, P/F ratio, anticoagulation and Rockwood Clinical Frailty index
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Patients admitted from 13th march 2020 to 17th october 2020
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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