Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06043115 |
| Other study ID # |
Akdeniz University Faculty |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 11, 2022 |
| Est. completion date |
December 15, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Akdeniz University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The coronavirus disease-19 (COVID-19), defined by the reporting of pneumonia cases of unknown
etiology at the end of 2019 in Wuhan, China, has spread worldwide, causing millions of
deaths. Despite the fact that more than two years have passed since the struggle against the
disease it continues to be an important public health problem.The increasing number of
critically ill patients with this pandemic caused a great demand for intensive care units
(ICU), and ICU capacity and staff had to be rapidly expanded in many countries. Similarly, in
various periods of the pandemic in Turkey, the capacity of many ICUs had to be increased. The
rates of admission to the ICU and death rates differed greatly from center to center due to
various factors such as ICU bed capacity and the duration of access to the ICU, patient
characteristics, and differences in the treatments applied. Determining the factors that may
be associated with mortality is important in terms of improving the ICU follow-up of patients
with COVID-19 and guiding their treatment.There is limited information about the
characteristics and mortality of Turkish patients with COVID-19 in the ICU. The aim of this
study is to determine the demographic, clinical and laboratory characteristics and the
factors affecting ICU mortality in COVID-19 patients followed in Akdeniz University Medical
Faculty Hospital since the beginning of the pandemic.
Description:
It was designed as a retrospective cohort study in which patients with a diagnosis of
COVID-19 hospitalized in the ICU between 11 March 2020 and 31 March 2022 were included.
Patients aged ≥18 years with a confrmed diagnosis of the severe acute respiratory syndrome
coronavirus-2 (SARS-CoV-2) infection by a positive real-time reverse-transcription polymerase
chain reaction test (RT-PCR) on a nasopharyngeal swab or or endotracheal aspirate were
included in the present study. The study data collected from the patient record at ICU
admission included demographic characteristics (age, sex, body mass index), smoking history,
comorbidities, vaccination status, Acute Physiology and Chronic Health Evaluation II (APACHE
II) score, Sequential Organ Failure Assessment (SOFA) score, laboratory findings, blood gas
analysis (PaO2/FiO2 ratio), oxygen device method, lenght of stay ICU and hospital duration
and COVID-19 related complications. Laboratory findings included a complete blood count,
coagulation testing, D-dimer, blood chemical analysis, C-reactive protein (CRP), assessment
of liver and renal function, procalcitonin, and microbial cultures results. Additional
adjunctive support, including extracorporeal membrane oxygenation (ECMO), prone positioning,
renal replacement therapy (RRT) were documented daily. Information on patient-specific
therapies, such as administration of hydroxychloroquine, antivirals, convalescent plasma and
plasmapheresis was also collected.
