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Characteristics and Outcome of Patients With COVID-19 in ICUs in South Tyrol

Sponsor
Institute of Mountain Emergency Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT05077319
Collaborator
Azienda Sanitaria dell'Alto Adige (Other)
550
Enrollment
1
Location
19
Actual Duration (Months)
29
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    550 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Characteristics and Outcome of Patients With COVID-19 Associated Respiratory Failure Treated in South Tyrol, Italy
    Actual Study Start Date :
    Mar 5, 2020
    Actual Primary Completion Date :
    Sep 20, 2021
    Actual Study Completion Date :
    Oct 4, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [Through study completion, an average of 1 year]

      Mortality (dead/alive) at discharge from the ICU is defined as primary outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eurac research Bolzano Italy 39100

    Sponsors and Collaborators

    • Institute of Mountain Emergency Medicine
    • Azienda Sanitaria dell'Alto Adige

    Investigators

    • Principal Investigator: Simon Rauch, MD, PhD, Institute of Mountain Emergency Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Simon Rauch, Senior researcher; MD, PhD, Institute of Mountain Emergency Medicine
    ClinicalTrials.gov Identifier:
    NCT05077319
    Other Study ID Numbers:
    • 1
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury

    Study Results

    No Results Posted as of Oct 14, 2021