Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04713852 |
| Other study ID # |
2020-174 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2020 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
September 2023 |
| Source |
Jessa Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
