Clinical trial NCT04775017: Delirium in Covid-19: Germany-wide Covid-19 Intensive Register
Official title: Delirium in Covid-19: Germany-wide Covid-19 Intensive Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Delirium
Covid19
Post Intensive Care Unit Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 2398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have COVID-19 and have been treated in an intensive care unit of Charité Universitätsmedizin and whose therapy has already been completed on 21.02.2022.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of delirium
timeFrame: 01.01.2020 - 21.02.2022
Secondary outcomes:
measure: Risk factors for severe COVID-19
timeFrame: 01.01.2020 - 21.02.2022
measure: Patient characteristics
timeFrame: 01.01.2020 - 21.02.2022
measure: Blood gas analysis
timeFrame: 01.01.2020-31.07.2020
measure: Enteral nutrition
timeFrame: 01.01.2020-31.07.2020
measure: Parenteral nutrition
timeFrame: 01.01.2020 - 21.02.2022
measure: Serum albumin
timeFrame: 01.01.2020 - 21.02.2022
measure: Total protein
timeFrame: 01.01.2020 - 21.02.2022
measure: Phosphate
timeFrame: 01.01.2020 - 21.02.2022
measure: Triglyceride
timeFrame: 01.01.2020 - 21.02.2022
measure: Caloric intake
timeFrame: 01.01.2020 - 21.02.2022
measure: Respiratory setting
timeFrame: 01.01.2020 - 21.02.2022
measure: Inflammatory laboratory parameter 1
timeFrame: 01.01.2020 - 21.02.2022
measure: Inflammatory laboratory parameter 2
timeFrame: 01.01.2020 - 21.02.2022
measure: Inflammatory laboratory parameter 3
timeFrame: 01.01.2020 - 21.02.2022
measure: Inflammatory laboratory parameter 4
timeFrame: 01.01.2020 - 21.02.2022
measure: Toxic-drug factors
timeFrame: 01.01.2020 - 21.02.2022
measure: Sociodemographic factors
timeFrame: 01.01.2020 - 21.02.2022
measure: Breathing hours
timeFrame: 01.01.2020 - 21.02.2022
measure: Length of intensive care unit stay
timeFrame: 01.01.2020 - 21.02.2022
measure: Length of hospital stay
timeFrame: 01.01.2020 - 31.07.2022
measure: Adverse events
timeFrame: 01.01.2020 - 21.02.2022
measure: Post Intensive Care Unit Syndrome (PICS)
timeFrame: 01.01.2020 - 21.02.2022
measure: In-hospital mortality
timeFrame: 01.01.2020 - 21.02.2022
measure: Mortality
timeFrame: 01.01.2020 - 31.08.2022
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum
Study officials:
affiliation: Charité - Universitäsmedizin Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: