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Completed

NCT Number: NCT04775017

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of delirium

    Time frame: 01.01.2020 - 21.02.2022

    Delirium is measured by validated screening scores.

Secondary outcomes

  1. Risk factors for severe COVID-19

    Time frame: 01.01.2020 - 21.02.2022

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

  2. Patient characteristics

    Time frame: 01.01.2020 - 21.02.2022

    Patient characteristics at hospital admission e.g. score level

  3. Blood gas analysis

    Time frame: 01.01.2020-31.07.2020

    Monitoring of blood gas analysis

  4. Enteral nutrition

    Time frame: 01.01.2020-31.07.2020

    Monitoring of enteral nutrition

  5. Parenteral nutrition

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of parenteral nutrition

  6. Serum albumin

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of serum albumin level

  7. Total protein

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of total protein level

  8. Phosphate

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of phosphate levels

  9. Triglyceride

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of triglyceride levels

  10. Caloric intake

    Time frame: 01.01.2020 - 21.02.2022

    Caloric intake is measured by total daily energy supply.

  11. Respiratory setting

    Time frame: 01.01.2020 - 21.02.2022

    Respiratory factors are measured respiratory setting

  12. Inflammatory laboratory parameter 1

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of interleukine level

  13. Inflammatory laboratory parameter 2

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of cytokine level

  14. Inflammatory laboratory parameter 3

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of big immune status

  15. Inflammatory laboratory parameter 4

    Time frame: 01.01.2020 - 21.02.2022

    Monitoring of t-cell population

  16. Toxic-drug factors

    Time frame: 01.01.2020 - 21.02.2022

    Toxic-drug factors are measured by concomitant medication.

  17. Sociodemographic factors

    Time frame: 01.01.2020 - 21.02.2022

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

  18. Breathing hours

    Time frame: 01.01.2020 - 21.02.2022

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

  19. Length of intensive care unit stay

    Time frame: 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

    Time frame: 01.01.2020 - 31.07.2022

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

  21. Adverse events

    Time frame: 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)

    Time frame: 01.01.2020 - 21.02.2022

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

  23. In-hospital mortality

    Time frame: 01.01.2020 - 21.02.2022

    Mortality is measured in the hospital

  24. Mortality

    Time frame: 01.01.2020 - 31.08.2022

    Mortality is measured until 180 days

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2021
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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