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Delirium in Covid-19: Germany-wide Covid-19 Intensive Register

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT04775017
Collaborator
(none)
1,000
Enrollment
1
Location
23
Anticipated Duration (Months)
43.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The global pandemic caused by the SARS-CoV-2 virus is confronting the German health system with a novel pathogen. This means that a timely evaluation of all available results is required. In the field of intensive care in particular, there are significant gaps in knowledge, particularly with regard to delirium. In this respect, this study also serves directly to investigate the pathways of delirium outcome in COVID-19 patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Delirium in Covid-19: Germany-wide Covid-19 Intensive Register
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of delirium [01.01.2020 - 21.02.2022]

      Delirium is measured by validated screening scores.

    Secondary Outcome Measures

    1. Risk factors for severe COVID-19 [01.01.2020 - 21.02.2022]

      Risk factors are defined according to actual literature e.g. obesity, diabetes or hypertension.

    2. Patient characteristics [01.01.2020 - 21.02.2022]

      Patient characteristics at hospital admission e.g. score level

    3. Blood gas analysis [01.01.2020-31.07.2020]

      Monitoring of blood gas analysis

    4. Enteral nutrition [01.01.2020-31.07.2020]

      Monitoring of enteral nutrition

    5. Parenteral nutrition [01.01.2020 - 21.02.2022]

      Monitoring of parenteral nutrition

    6. Serum albumin [01.01.2020 - 21.02.2022]

      Monitoring of serum albumin level

    7. Total protein [01.01.2020 - 21.02.2022]

      Monitoring of total protein level

    8. Phosphate [01.01.2020 - 21.02.2022]

      Monitoring of phosphate levels

    9. Triglyceride [01.01.2020 - 21.02.2022]

      Monitoring of triglyceride levels

    10. Caloric intake [01.01.2020 - 21.02.2022]

      Caloric intake is measured by total daily energy supply.

    11. Respiratory setting [01.01.2020 - 21.02.2022]

      Respiratory factors are measured respiratory setting

    12. Inflammatory laboratory parameter 1 [01.01.2020 - 21.02.2022]

      Monitoring of interleukine level

    13. Inflammatory laboratory parameter 2 [01.01.2020 - 21.02.2022]

      Monitoring of cytokine level

    14. Inflammatory laboratory parameter 3 [01.01.2020 - 21.02.2022]

      Monitoring of big immune status

    15. Inflammatory laboratory parameter 4 [01.01.2020 - 21.02.2022]

      Monitoring of t-cell population

    16. Toxic-drug factors [01.01.2020 - 21.02.2022]

      Toxic-drug factors are measured by concomitant medication.

    17. Sociodemographic factors [01.01.2020 - 21.02.2022]

      Sociodemographic factors are measured by Audit, Fagerström, occupation, age, gender, cognitive status.

    18. Breathing hours [01.01.2020 - 21.02.2022]

      Breathing hours are measured by non-invasive and invasive ventilation.

    19. Length of intensive care unit stay [01.01.2020 - 21.02.2022]

      Length of intensive care unit stay is measured in days of stay in the intensive care unit.

    20. Length of hospital stay [01.01.2020 - 31.07.2020]

      Length of hospital stay is measured in days of stay in hospital.

    21. Adverse events [01.01.2020 - 21.02.2022]

      Adverse Events defined by thromboembolic events, nosocomial infections, septic shock, acute renal failure, heart attack, post-intensive care syndrome and death are recorded until hospital discharge.

    22. Post Intensive Care Unit Syndrome (PICS) [01.01.2020 - 21.02.2022]

      Post Intensive Care Unit Syndrome (PICS) is measured by a validated battery (composite endpoint).

    23. In-hospital mortality [01.01.2020 - 21.02.2022]

      Mortality is measured in the hospital

    24. Mortality [01.01.2020 - 21.02.2022]

      Mortality is measured until 180 days

    Eligibility Criteria

    Criteria

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

    All patients with SARS-CoV-2 positive Covid-19 disease

    • Age≥18 years

    • Proven by positive PCR tests from nasal/ throat swabs as well as samples from the deep respiratory tract.

    • Period 01.01.2020 to 21.02.2022

    Exclusion Criteria:
    • NONE

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Prof., Charité - Universitäsmedizin Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT04775017
    Other Study ID Numbers:
    • COVID-19-Delirium
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Delirium

    Study Results

    No Results Posted as of May 23, 2022