- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04758039
Clinical Characteristics and In-hospital Death of a Chilean COVID-19 Prospective Cohort
Clinical Characteristics and In-hospital Death During the First 100 Days of the COVID-19 Pandemic in Chile: A Prospective Cohort Study From a University Hospital
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This is a prospective cohort study of adult inpatients at University of Chile Clinical Hospital, located in Santiago, Chile. We enrolled all patients aged over 18 years detected with COVID-19 admitted to the emergency department between March 1-June 11, 2020 through prospective identification using daily admission records. Briefly, COVID-19 diagnosis was made when patients had clinical findings of acute respiratory illness together with i) a positive result on reverse transcriptase chain reaction polymerase (RT-PCR) assay performed on a nasopharyngeal swab; and/or ii) chest computed tomography (CT) with typical findings of COVID-19 and absence of an alternative diagnosis. We intended to include all admitted patients during the first 100 days of the pandemic; therefore, no sample size calculation was performed. We excluded patients with length of stay less than 24 hours, nosocomial SARS-CoV-2 infection, and asymptomatic patients admitted for causes unrelated to SARS-CoV-2 infection regardless of their admission RT-PCR result.
All data were prospectively recorded for each included patient at admission and then daily until the end of the follow-up. Records were consulted by trained physicians, using a standardized data collection form, and then checked by a team of four physicians. Data discrepancy was agreed between the same clinicians.
Recorded data included demographic characteristics, comorbidities, disease onset time, associated symptoms, vital signs at the emergency department, laboratory test performed within 24 hours after admission, characteristics of the first chest CT, medication and supportive care provided, and length of stay at the hospital.
The use of antibiotics, antiviral therapy, corticosteroids, advanced oxygen delivery techniques, need for invasive mechanical ventilation (IMV), awake and ventilated prone position, use of vasopressor drugs, and need for renal replacement therapy (RRT) were explicitly recorded. Clinical management and use of these therapies were based on national recommendations from scientific societies and local protocols. Outcome collection and assignment are explained below.
Laboratory confirmation of SARS-CoV-2 infection was made using RT-PCR of nasopharyngeal swabs. All laboratory, microbiologic, and radiologic assessments were performed at the discretion of the treating physicians who were encouraged to follow local clinical guidelines. Film-array on the nasopharyngeal swab was performed for viral co-infection assessment, and urinary antigens. (pneumococcal and legionella) and blood cultures were performed for bacterial co-infection assessment. Chest radiographs and CT were also performed for all inpatients by experienced radiologists and classified as COVID-19-unrelated, typical or atypical pattern, and unspecified.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Región Metropolitana
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Santiago, Región Metropolitana, Chile
- Hospital Clínico de la Universidad de Chile
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients over 18 years
- Diagnosis of COVID-19 defined by clinical findings of acute respiratory illness (as per WHO guidelines) together with i) a positive result on reverse transcriptase chain reaction polymerase (RT-PCR) assay performed on a nasopharyngeal swab; and/or ii) chest computed tomography (CT) with typical findings of COVID-19 and absence of an alternative diagnosis
Exclusion Criteria:
- Length of hospital stay less than 24 hours
- Nosocomial SARS-CoV-2 infection
- Asymptomatic patients admitted for causes not related to coronavirus infection regardless their admission RT-PCR result
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
In hospital Mortality
Tidsramme: March 13th to July 10th 2020
|
Death while hospitalized
|
March 13th to July 10th 2020
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Admission to an intensive care unit (ICU)
Tidsramme: March 13th to July 10th 2020
|
Admission to an intensive care unit (ICU)
|
March 13th to July 10th 2020
|
|
Use of invasive mechanical ventilation (IMV)
Tidsramme: March 13th to July 10th 2020
|
Days from admission and length of IMV
|
March 13th to July 10th 2020
|
|
Presence of thromboembolic disease (deep vein thrombosis, pulmonary embolism or both)
Tidsramme: March 13th to July 10th 2020
|
Described as a positive US exploration of the arms or legs, and a positive CT Scan
|
March 13th to July 10th 2020
|
|
Acute kidney injury (AKI)
Tidsramme: March 13th to July 10th 2020
|
AKI, as per defined by the Kidney Disease Improving Global Outcomes (KDIGO) initiative
|
March 13th to July 10th 2020
|
|
Renal replacement therapy (RRT).
Tidsramme: March 13th to July 10th 2020
|
Days from admission and length of RRT
|
March 13th to July 10th 2020
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Francisco J Gonzalez, MD, University of Chile
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- COVID-19
- HFNC
- Coronavirusinfektion
- SARS-CoV-2
- Clinical Scenarios
- Hospitalism
- Hospitalist
- Teaching Hospital
- Vågen tilbøjelig positionering
- Ventilated Prone Positioning
- High Flow næsekanyle
- Invasiv mekanisk ventilation
- Modified Charlson Comorbidity Index
- Charlson Comorbidity Index
- Dødelighed på hospitalet
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OAIC N° 1119/20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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