Clinical Characteristics and Outcomes of 187 Critically Ill Patients With Coronavirus Disease 2019 (COVID-19)

Study Overview
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Brief Summary
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This case series describes the clinical characteristics, treatment and outcomes of patients with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary hospital in Northeast Brazil.

Detailed Description
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This retrospective observational study will be carried out at Hospital São Domingos, state of Maranhao, Brasil. It is a tertiary hospital with 450 beds and six Intensive Care Units (ICU) with a total of 63 beds. With the admission of the first patients with Coronavirus Disease 2019 (COVID-19) as of March 20, we initially made available a 12 beds ICU exclusively for the treatment of patients with COVID-19. At the beginning of April, the number of beds was increased to 35 and, immediately afterwards, two semi-intensive units (16 and 21 beds) were created for patients in need of non-invasive respiratory support, with the 35 beds ICU 35 dedicated to receive only patients in need of high-level support (usually invasive mechanical ventilation) with or without other organ dysfunctions. In the period from March 20 to June 15, 2020, 935 patients with confirmed diagnosis (RT-PCR) of COVID-19 were admitted to the hospital and 187 of them were treated in the ICU. Data were obtained from the hospital's electronic medical record. Demographic and severity data included age, sex, Simplified Acute Physiology 3 (SAPS 3) and Sequential Organ Failure Assessment (SOFA) scores at admission, nutritional risk determined by Nutritional Risk Screening 2002 (NRS-2002) and commodities. Clinical and laboratory data on arrival at the ICU including Partial pressure of oxygen in arterial bood / Inspired fraction of oxygen (PaO2 / FIO2) complete blood count and PCR D-dimer, ferritin, fibrinogen and lactic acid dehydrogenasew (LDH). Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position, ECMO and vasoactive drugs. The main complications, acute kidney injury requiring hemodialysis, secondary infectious complications will be documented as well as the outcomes.

Official Title
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Clinical Characteristics and Outcomes of 187 Critically Ill Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Other: demographic and clinical data obtained from hospital's electronic medical record.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the 35 beds ICU between March 20 and June 15, 2020 with laboratory confirmed diagnosis of COVID-19 (RT-PCR). Exclusion Criteria: Patients admitted to the ICU in which the RT-PCR was negative, and patients that did not require high level life support (RRT, Prone position, ECMO, hemodymnamic monitoring and support).

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: demographic and clinical data obtained from hospital's electronic medical record.|This retrospective observational study. . Demographic and severity data will include age, sex, SAPS 3 and SOFA scores at admission, nutritional risk determined by NRS-2002 and commodities. Clinical and laboratory data on arrival at the ICU including PaO2 / FIO2, blood count and PCR D-dimer, ferritin, fibrinogen, DHL. Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position and ECMO and vasoactive drugs. The main complications, acute kidney injury requiring renal replacement therapy, secondary infectious complications will be documented as well as the outcomes.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome 30 days after ICU admission | A seven-category ordinal scale consisting of: 1. Death; 2. hospitalized, on invasive mechanical ventilation; 3. hospitalized, on non-invasive ventilation; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized not requiring supplemental oxygen; 6. hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7 Not hospitalized | 30 days after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, critically ill patients, outcomes, treatment