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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04758039
Enrollment
395
Registered
2021-02-17
Start date
2020-03-13
Completion date
2020-07-10
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corona Virus Infection

Keywords

Coronavirus Infection, COVID-19, SARS-CoV 2, Clinical Scenarios, Hospitalism, Hospitalist, Teaching Hospital, Awake Prone Positioning, Ventilated Prone Positioning, High Flow Nasal Cannula, HFNC, Invasive Mechanical Ventilation, Modified Charlson Comorbidity Index, Charlson Comorbidity Index, In-Hospital Mortality

Brief summary

The investigators planned to examine a cohort of admitted patients at University of Chile Clinical Hospital with COVID-19 diagnosis. Authors report data on mortality, ICU admission, need of invasive mechanical ventilation, awake and ventilated prone positioning, use of High Flow Nasal Cannula, Thromboembolic disease, Acute Kidney Injury (AKI) and Renal Replacement Therapy. Additionally, the risk of in-hospital death according to chronic disease burden and severity of illness at admission was assessed.

Detailed description

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.

Interventions

None listed

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
In hospital MortalityMarch 13th to July 10th 2020Death while hospitalized

Secondary

MeasureTime frameDescription
Admission to an intensive care unit (ICU)March 13th to July 10th 2020Admission to an intensive care unit (ICU)
Use of invasive mechanical ventilation (IMV)March 13th to July 10th 2020Days from admission and length of IMV
Presence of thromboembolic disease (deep vein thrombosis, pulmonary embolism or both)March 13th to July 10th 2020Described as a positive US exploration of the arms or legs, and a positive CT Scan
Acute kidney injury (AKI)March 13th to July 10th 2020AKI, as per defined by the Kidney Disease Improving Global Outcomes (KDIGO) initiative
Renal replacement therapy (RRT).March 13th to July 10th 2020Days from admission and length of RRT

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026