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

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ClinicalTrials.gov Identifier: NCT04454372
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
José Raimundo Araujo de Azevedo, Hospital Sao Domingos

Brief Summary:
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.

Condition or disease Intervention/treatment
COVID-19 Other: demographic and clinical data obtained from hospital's electronic medical record.

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Characteristics and Outcomes of 187 Critically Ill Patients With COVID-19
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Outcome 30 days after ICU admission [ Time Frame: 30 days after 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



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All critically ill patients admitted to the 35 beds ICU dedicated to COVID-19 in the period of March 20 and June 15, 2020 with laboratory confirmed diagnosis of COVID-19. Patients that could be managed without invasive mechanical ventilation and that did not require other high level life support were managed in one of the semi intensive units (16 and 21 beds).
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454372


Contacts
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Contact: JOSE R AZEVEDO, MD, PhD +559832168110 jrazevedo47@gmail.com

Sponsors and Collaborators
Hospital Sao Domingos
Investigators
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Study Chair: JOSE AZEVEDO, MD Hospital Sao Domingos
Publications of Results:

Other Publications:

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Responsible Party: José Raimundo Araujo de Azevedo, Principal investigator, Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT04454372    
Other Study ID Numbers: covid-19 ICU
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Raimundo Araujo de Azevedo, Hospital Sao Domingos:
COVID-19
critically ill patients
outcomes
treatment
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes