Intensive Care Unit DeliriumNCT04775017
Delirium in Covid-19: Germany-wide Covid-19 Intensive Register
An observational study of Intensive Care Unit Delirium and Covid19, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Delirium, Covid19, Post Intensive Care Unit Syndrome
- How many people
- 2,398 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum
Berlin, 13353
About this study
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.
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Delirium is measured by validated screening scores.
Measured: 01.01.2020 - 21.02.2022
Secondary outcomes (24)
Risk factors for severe COVID-19
Risk factors are defined according to actual literature e.g. obesity, diabetes or hypertension.
Measured: 01.01.2020 - 21.02.2022
Patient characteristics
Patient characteristics at hospital admission e.g. score level
Measured: 01.01.2020 - 21.02.2022
Blood gas analysis
Monitoring of blood gas analysis
Measured: 01.01.2020-31.07.2020
Enteral nutrition
Monitoring of enteral nutrition
Measured: 01.01.2020-31.07.2020
Parenteral nutrition
Monitoring of parenteral nutrition
Measured: 01.01.2020 - 21.02.2022
Serum albumin
Monitoring of serum albumin level
Measured: 01.01.2020 - 21.02.2022
Total protein
Monitoring of total protein level
Measured: 01.01.2020 - 21.02.2022
Phosphate
Monitoring of phosphate levels
Measured: 01.01.2020 - 21.02.2022
Triglyceride
Monitoring of triglyceride levels
Measured: 01.01.2020 - 21.02.2022
Caloric intake
Caloric intake is measured by total daily energy supply.
Measured: 01.01.2020 - 21.02.2022
Respiratory setting
Respiratory factors are measured respiratory setting
Measured: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 1
Monitoring of interleukine level
Measured: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 2
Monitoring of cytokine level
Measured: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 3
Monitoring of big immune status
Measured: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 4
Monitoring of t-cell population
Measured: 01.01.2020 - 21.02.2022
Toxic-drug factors
Toxic-drug factors are measured by concomitant medication.
Measured: 01.01.2020 - 21.02.2022
Sociodemographic factors
Sociodemographic factors are measured by Audit, Fagerström, occupation, age, gender, cognitive status.
Measured: 01.01.2020 - 21.02.2022
Breathing hours
Breathing hours are measured by non-invasive and invasive ventilation.
Measured: 01.01.2020 - 21.02.2022
Length of intensive care unit stay
Length of intensive care unit stay is measured in days of stay in the intensive care unit.
Measured: 01.01.2020 - 21.02.2022
Length of hospital stay
Length of hospital stay is measured in days of stay in hospital.
Measured: 01.01.2020 - 31.07.2022
Adverse events
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.
Measured: 01.01.2020 - 21.02.2022
Post Intensive Care Unit Syndrome (PICS)
Post Intensive Care Unit Syndrome (PICS) is measured by a validated battery (composite endpoint).
Measured: 01.01.2020 - 21.02.2022
In-hospital mortality
Mortality is measured in the hospital
Measured: 01.01.2020 - 21.02.2022
Mortality
Mortality is measured until 180 days
Measured: 01.01.2020 - 31.08.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2021
- Primary completion21 Feb 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charité - Universitäsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775017
- Sponsor's protocol ID
- COVID-19-Delirium
- Status last verified
- Oct 2024
- First submitted
- 21 Jan 2021
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium in Covid-19: Germany-wide Covid-19 Intensive Register
- ClinicalTrials.gov ID
- NCT04775017
- Acronym / sponsor ID
- COVID-19-Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,398 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of delirium
Time frame: 01.01.2020 - 21.02.2022
Delirium is measured by validated screening scores.
24 secondary outcomes
Risk factors for severe COVID-19
Time frame: 01.01.2020 - 21.02.2022
Patient characteristics
Time frame: 01.01.2020 - 21.02.2022
Blood gas analysis
Time frame: 01.01.2020-31.07.2020
Enteral nutrition
Time frame: 01.01.2020-31.07.2020
Parenteral nutrition
Time frame: 01.01.2020 - 21.02.2022
Serum albumin
Time frame: 01.01.2020 - 21.02.2022
Total protein
Time frame: 01.01.2020 - 21.02.2022
Phosphate
Time frame: 01.01.2020 - 21.02.2022
Triglyceride
Time frame: 01.01.2020 - 21.02.2022
Caloric intake
Time frame: 01.01.2020 - 21.02.2022
Respiratory setting
Time frame: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 1
Time frame: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 2
Time frame: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 3
Time frame: 01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 4
Time frame: 01.01.2020 - 21.02.2022
Toxic-drug factors
Time frame: 01.01.2020 - 21.02.2022
Sociodemographic factors
Time frame: 01.01.2020 - 21.02.2022
Breathing hours
Time frame: 01.01.2020 - 21.02.2022
Length of intensive care unit stay
Time frame: 01.01.2020 - 21.02.2022
Length of hospital stay
Time frame: 01.01.2020 - 31.07.2022
Adverse events
Time frame: 01.01.2020 - 21.02.2022
Post Intensive Care Unit Syndrome (PICS)
Time frame: 01.01.2020 - 21.02.2022
In-hospital mortality
Time frame: 01.01.2020 - 21.02.2022
Mortality
Time frame: 01.01.2020 - 31.08.2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charité - Universitäsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Delirium and Covid19, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: 01.01.2020 - 21.02.2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.