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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05077319
Other study ID # 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2020
Est. completion date October 4, 2021

Study information

Verified date October 2021
Source Institute of Mountain Emergency Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators retrospectively investigate the epidemiology, clinical characteristics and therapeutic interventions of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy.


Description:

In this observational, retrospective study the epidemiology, characteristics, therapeutic interventions and outcome of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy, are assessed. Data extracted from the medical patients' records include type and duration of respiratory support (high-flow nasal oxygen, non-invasive ventilation, invasive ventilation), need for tracheostomy, vasopressor needs, antibiotic therapy, corticosteroid treatment, laboratory values (interleukin-6, C-reactive protein, procalcitonin, D-dimer, lymphocyte count), lengths of stay in the ICU and mortality.


Recruitment information / eligibility

Status Completed
Enrollment 550
Est. completion date October 4, 2021
Est. primary completion date September 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure Exclusion Criteria: - SARS-CoV-2 patients admitted to the intensive care units in South Tyrol for other pathologies (i.e., not respiratory failure)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Eurac research Bolzano

Sponsors (2)

Lead Sponsor Collaborator
Institute of Mountain Emergency Medicine Azienda Sanitaria dell'Alto Adige

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality (dead/alive) at discharge from the ICU is defined as primary outcome Through study completion, an average of 1 year
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