DeliriumNCT05913531
Retrospective Evaluation of Delirium Data From Previous Study Patients for Studies at the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
An observational study of Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Evaluation of several studies of the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF to create a register with the delirium data from anesthesiology study patients between 18 - 100 years. The primary purpose of the register is to assess factors influencing the development of delirium. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Delirium
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
Who may be able to join
- Male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin
Berlin, 13355
Claudia Spies, MD, Prof., +49 30 450 55 11 02, claudia.spies@charite.de
Claudia Spies, MD, Prof.
About this study
Evaluation of several studies of the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF to create a register with the delirium data from anesthesiology study patients between 18 - 100 years. The primary purpose of the register is to assess factors influencing the development of delirium.
In a subproject, risk factors that may lead to the development of postoperative delirium in the elderly will be evaluated with regard to gender differences using patients from the age of 60 with different surgical procedures. The risk factors examined are based on the evidence-based and consensus-based recommendations of the ESA guideline and literature review. In addition, the delirium incidence rate and the delirium severity is examined regarding gender differences.
- Conditions
- Delirium
- Medical subject headings
- Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Validated delirium scoring (points, duration and severity)
Measured: Up to 5 years
Secondary outcomes (57)
Sedation scales
Sedation is measured by the Richmond Agitation Sedation Scale
Measured: Up to 5 years
Socioeconomic information 1
Soci-economic information is collected by FIMA
Measured: Up to 5 years
Socioeconomic information 2
Soci-economic information is collected by the Nikolaus-score (social situation), 1. Subscale
Measured: Up to 5 years
Socioeconomic information 3
Soci-economic information is collected by items on socioeconomic status from the Federal Health Survey of 1998
Measured: Up to 5 years
Comorbidities
Comorbidities are new diagnoses from hospital records.
Measured: Up to 5 years
Charlson comorbidity index
Comorbidity scores
Measured: Up to 5 years
Lifestyle risks 1
Consumption of alcohol is measured by AUDIT (Alcohol Use Disorders Identification Tests)
Measured: Up to 5 years
Lifestyle risks 2
Consumption of and nicotine is measured by Fagerström Test for Cigarette Dependence (FTCD). Questionnaire scored 0-10 points with Total Score equal to the sum of all points
Measured: Up to 5 years
Lifestyle risks 3
Consumption of nicotine is measured by Smocking Pack Years (SPY)
Measured: Up to 5 years
Lifestyle risks 4
Previous consumption of nicotine is measured by History of Smoking.
Measured: Up to 5 years
Level of education
Level of education is measured by ISCED (International Standard Classification of Education)
Measured: Up to 5 years
Quality of life - relatives
Quality of life is measured by CarerQoL
Measured: Up to 5 years
Quality of life - self 1
Quality of life is measured by EQ-5D.An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.
Measured: Up to 5 years
Quality of life - self 2
Quality of life is measured by WHO-5. WHO-5 is a short and generic global rating scale measuring subjective well-being, the respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score ranges from 0 (absence of well-being) to 25 (maximal well-being). Scores are then converted to a percentage scale from 0 (absent) to 100 (maximal). Higher scores represent greater psychological well-being.
Measured: Up to 5 years
Quality of life - self 3
Quality of life is measured by SF-12 (Short form health survey)
Measured: Up to 5 years
Functional impairment (IADL) 1
Instrumental Activities of Daily Living (IADLs) < 8
Measured: Up to 5 years
Functional impairment (ADL) 2
Activities of Daily Living (ADLs) < 100
Measured: Up to 5 years
Depression 1
Depression 1 is measured by PHQ-8 (Patient Health Questionnaire depression scale)
Measured: Up to 5 years
Depression 2
Depression 2 is measured by GDS (Geriatric Depression Scale)
Measured: Up to 5 years
Depression 3
Depression 3 is measured by HADS (Hospital Anxiety and Depression Scale)
Measured: Up to 5 years
Depression 4
Depression 4 is measured by CDS (Cornel Depression Scale)
Measured: Up to 5 years
Anxiety scales 1
Anxiety is measured by GAD-7 (Generalized Anxiety Disorder 7)
Measured: Up to 5 years
Anxiety scale 2
Anxiety 2 is measured by FAS (Faces Anxiety Scale)
Measured: Up to 5 years
Anxiety scale 2
Anxiety 2 is measured by GAD-7
Measured: Up to 5 years
Pain
Pain is measured by numeric pain scales (minimum = 0, maximum = 10).
Measured: Up to 5 years
Type of concomitant medication
The medication administered during the hospital stay is documented.
Measured: Up to 5 years
Anticholinergic Load
Measured by anticholinergic drug scale
Measured: Up to 5 years
Frailty
Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.
Measured: Up to 5 years
Nutritional status 1
Nutritional status 1 is measured by calf circumference
Measured: Up to 5 years
Nutritional status 2
Nutritional status 2 is measured by arm circumference
Measured: Up to 5 years
Nutritional status 3
Nutritional status 3 is measured by changes in weight
Measured: Up to 5 years
Nutritional status 4
Nutritional status 4 is measured by changes in body mass index
Measured: Up to 5 years
Nutritional status 5
Nutritional status 5 is measured by previous weight history (3 months)
Measured: Up to 5 years
Nutritional status 6
Nutritional status 6 is measured by Medi-Score
Measured: Up to 5 years
Nutritional status 7
Nutritional status 7 is measured by MNA-SF
Measured: Up to 5 years
Nutritional status 8
Nutritional status 8 is measured by Sarcopenia
Measured: Up to 5 years
Nutritional status 9
Nutritional status 9 is measured by Nutritional Risk Screening (NRS 2002)
Measured: Up to 5 years
Nutritional status 10
Nutritional status 10 is measured by AKE Screening
Measured: Up to 5 years
Mobility 1
Mobility 1 is measured with the Timed up and Go
Measured: Up to 5 years
Mobility 2
Mobility 2 is measured with a walking test: Slowness: Calculated after walking 3 meters, adjusted for sex and height, according to Fried. The cut-off points for 3 meters were established as, in men: height ≤173 cm and time ≥4.59 s (equivalent to 0.65 m/s); height >1.73 cm and time ≥3.93 s (equivalent to 0.76 m/s); and for women: height ≤1.59 cm and time ≥4.59 s (0.65 m/s); and height >1.59 cm and time ≥3.93 s (0.76 m/s).
Measured: Up to 5 years
Number of participants with changes in laboratory values 1
Laboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.
Measured: Up to 5 years
Number of participants with changes in laboratory values 2
Laboratory results in the hospital from serum samples
Measured: Up to 5 years
Number of participants with changes in laboratory values 3
Laboratory results in the hospital from urine samples
Measured: Up to 5 years
Number of participants with changes in laboratory values 4
Laboratory results in the hospital from liquor samples
Measured: Up to 5 years
Depth of sedation
The sedation was measured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.
Measured: Up to 5 years
Type of operation
Type of operation is measured by OPS-Code
Measured: Up to 5 years
Duration of operation
Type of operation is measured in minutes
Measured: Up to 5 years
Type of anesthesia
There are four main categories of anesthesia used during surgery and other procedures: general anesthesia, regional anesthesia, sedation (sometimes called "monitored anesthesia care"), and local anesthesia.
Measured: Up to 5 years
Duration of anesthesia
Duration of anesthesia is measured in minutes.
Measured: Up to 5 years
Length of hospital stay
Hospital stay is measured in days.
Measured: Up to 5 years
Intensive care unit stay
Intensive care unit stay is measured in hours.
Measured: Up to 5 years
Organ complications
Organ complications are recorded in hospital records
Measured: Up to 5 years
Hospital discharge criteria
Discharge criteria are measured at hospital discharge by Post Anesthetic Discharge Scoring System (PADS) Score
Measured: Up to 5 years
Mortality
Mortality rate is measured after 1,2,3,4 and 5 years
Measured: Up to 5 years
Study data
Identification of study data with a high impact on delirium from the study databases
Measured: Up to 5 years
Sleeping items
Questions measuring personal satisfaction with sleep quality and duration As measured by questions measuring personal satisfaction with sleep quality and duration
Measured: Up to 5 years
Circadian rhythm variables
Items measuring circadian rhythm variables e.g. Zeitgebers
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start23 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 5,000 participants (estimated)
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, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913531
- Sponsor's protocol ID
- Retro-Delirium
- Status last verified
- Feb 2025
- First submitted
- 11 May 2023
- Last updated
- 4 Feb 2025
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Delirium Data From Previous Study Patients for Studies at the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
- ClinicalTrials.gov ID
- NCT05913531
- Acronym / sponsor ID
- Retro-Delirium
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2023 (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.
Evaluation of several studies of the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF to create a register with the delirium data from anesthesiology study patients between 18 - 100 years. The primary purpose of the register is to assess factors influencing the development of delirium.
In a subproject, risk factors that may lead to the development of postoperative delirium in the elderly will be evaluated with regard to gender differences using patients from the age of 60 with different surgical procedures. The risk factors examined are based on the evidence-based and consensus-based recommendations of the ESA guideline and literature review. In addition, the delirium incidence rate and the delirium severity is examined regarding gender differences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
Key inclusion criteria (1 listed)
- Male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
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
Delirium
Time frame: Up to 5 years
Validated delirium scoring (points, duration and severity)
57 secondary outcomes
Sedation scales
Time frame: Up to 5 years
Socioeconomic information 1
Time frame: Up to 5 years
Socioeconomic information 2
Time frame: Up to 5 years
Socioeconomic information 3
Time frame: Up to 5 years
Comorbidities
Time frame: Up to 5 years
Charlson comorbidity index
Time frame: Up to 5 years
Lifestyle risks 1
Time frame: Up to 5 years
Lifestyle risks 2
Time frame: Up to 5 years
Lifestyle risks 3
Time frame: Up to 5 years
Lifestyle risks 4
Time frame: Up to 5 years
Level of education
Time frame: Up to 5 years
Quality of life - relatives
Time frame: Up to 5 years
Quality of life - self 1
Time frame: Up to 5 years
Quality of life - self 2
Time frame: Up to 5 years
Quality of life - self 3
Time frame: Up to 5 years
Functional impairment (IADL) 1
Time frame: Up to 5 years
Functional impairment (ADL) 2
Time frame: Up to 5 years
Depression 1
Time frame: Up to 5 years
Depression 2
Time frame: Up to 5 years
Depression 3
Time frame: Up to 5 years
Depression 4
Time frame: Up to 5 years
Anxiety scales 1
Time frame: Up to 5 years
Anxiety scale 2
Time frame: Up to 5 years
Anxiety scale 2
Time frame: Up to 5 years
Pain
Time frame: Up to 5 years
Type of concomitant medication
Time frame: Up to 5 years
Anticholinergic Load
Time frame: Up to 5 years
Frailty
Time frame: Up to 5 years
Nutritional status 1
Time frame: Up to 5 years
Nutritional status 2
Time frame: Up to 5 years
Nutritional status 3
Time frame: Up to 5 years
Nutritional status 4
Time frame: Up to 5 years
Nutritional status 5
Time frame: Up to 5 years
Nutritional status 6
Time frame: Up to 5 years
Nutritional status 7
Time frame: Up to 5 years
Nutritional status 8
Time frame: Up to 5 years
Nutritional status 9
Time frame: Up to 5 years
Nutritional status 10
Time frame: Up to 5 years
Mobility 1
Time frame: Up to 5 years
Mobility 2
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
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 Delirium, 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 1 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Spies, MD Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Up to 5 years). 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 4 Feb 2025.