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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Claudia Spies, MD Prof. contact

+49 30 450 55 11 02

claudia.spies@charite.de

Germany1 site, 1 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.

    Recruiting

Other trials in Germany

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.

  1. Delirium

    Validated delirium scoring (points, duration and severity)

    Measured: Up to 5 years

Secondary outcomes (57)
  1. Sedation scales

    Sedation is measured by the Richmond Agitation Sedation Scale

    Measured: Up to 5 years

  2. Socioeconomic information 1

    Soci-economic information is collected by FIMA

    Measured: Up to 5 years

  3. Socioeconomic information 2

    Soci-economic information is collected by the Nikolaus-score (social situation), 1. Subscale

    Measured: Up to 5 years

  4. 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

  5. Comorbidities

    Comorbidities are new diagnoses from hospital records.

    Measured: Up to 5 years

  6. Charlson comorbidity index

    Comorbidity scores

    Measured: Up to 5 years

  7. Lifestyle risks 1

    Consumption of alcohol is measured by AUDIT (Alcohol Use Disorders Identification Tests)

    Measured: Up to 5 years

  8. 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

  9. Lifestyle risks 3

    Consumption of nicotine is measured by Smocking Pack Years (SPY)

    Measured: Up to 5 years

  10. Lifestyle risks 4

    Previous consumption of nicotine is measured by History of Smoking.

    Measured: Up to 5 years

  11. Level of education

    Level of education is measured by ISCED (International Standard Classification of Education)

    Measured: Up to 5 years

  12. Quality of life - relatives

    Quality of life is measured by CarerQoL

    Measured: Up to 5 years

  13. 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

  14. 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

  15. Quality of life - self 3

    Quality of life is measured by SF-12 (Short form health survey)

    Measured: Up to 5 years

  16. Functional impairment (IADL) 1

    Instrumental Activities of Daily Living (IADLs) < 8

    Measured: Up to 5 years

  17. Functional impairment (ADL) 2

    Activities of Daily Living (ADLs) < 100

    Measured: Up to 5 years

  18. Depression 1

    Depression 1 is measured by PHQ-8 (Patient Health Questionnaire depression scale)

    Measured: Up to 5 years

  19. Depression 2

    Depression 2 is measured by GDS (Geriatric Depression Scale)

    Measured: Up to 5 years

  20. Depression 3

    Depression 3 is measured by HADS (Hospital Anxiety and Depression Scale)

    Measured: Up to 5 years

  21. Depression 4

    Depression 4 is measured by CDS (Cornel Depression Scale)

    Measured: Up to 5 years

  22. Anxiety scales 1

    Anxiety is measured by GAD-7 (Generalized Anxiety Disorder 7)

    Measured: Up to 5 years

  23. Anxiety scale 2

    Anxiety 2 is measured by FAS (Faces Anxiety Scale)

    Measured: Up to 5 years

  24. Anxiety scale 2

    Anxiety 2 is measured by GAD-7

    Measured: Up to 5 years

  25. Pain

    Pain is measured by numeric pain scales (minimum = 0, maximum = 10).

    Measured: Up to 5 years

  26. Type of concomitant medication

    The medication administered during the hospital stay is documented.

    Measured: Up to 5 years

  27. Anticholinergic Load

    Measured by anticholinergic drug scale

    Measured: Up to 5 years

  28. Frailty

    Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.

    Measured: Up to 5 years

  29. Nutritional status 1

    Nutritional status 1 is measured by calf circumference

    Measured: Up to 5 years

  30. Nutritional status 2

    Nutritional status 2 is measured by arm circumference

    Measured: Up to 5 years

  31. Nutritional status 3

    Nutritional status 3 is measured by changes in weight

    Measured: Up to 5 years

  32. Nutritional status 4

    Nutritional status 4 is measured by changes in body mass index

    Measured: Up to 5 years

  33. Nutritional status 5

    Nutritional status 5 is measured by previous weight history (3 months)

    Measured: Up to 5 years

  34. Nutritional status 6

    Nutritional status 6 is measured by Medi-Score

    Measured: Up to 5 years

  35. Nutritional status 7

    Nutritional status 7 is measured by MNA-SF

    Measured: Up to 5 years

  36. Nutritional status 8

    Nutritional status 8 is measured by Sarcopenia

    Measured: Up to 5 years

  37. Nutritional status 9

    Nutritional status 9 is measured by Nutritional Risk Screening (NRS 2002)

    Measured: Up to 5 years

  38. Nutritional status 10

    Nutritional status 10 is measured by AKE Screening

    Measured: Up to 5 years

  39. Mobility 1

    Mobility 1 is measured with the Timed up and Go

    Measured: Up to 5 years

  40. 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

  41. 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

  42. Number of participants with changes in laboratory values 2

    Laboratory results in the hospital from serum samples

    Measured: Up to 5 years

  43. Number of participants with changes in laboratory values 3

    Laboratory results in the hospital from urine samples

    Measured: Up to 5 years

  44. Number of participants with changes in laboratory values 4

    Laboratory results in the hospital from liquor samples

    Measured: Up to 5 years

  45. 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

  46. Type of operation

    Type of operation is measured by OPS-Code

    Measured: Up to 5 years

  47. Duration of operation

    Type of operation is measured in minutes

    Measured: Up to 5 years

  48. 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

  49. Duration of anesthesia

    Duration of anesthesia is measured in minutes.

    Measured: Up to 5 years

  50. Length of hospital stay

    Hospital stay is measured in days.

    Measured: Up to 5 years

  51. Intensive care unit stay

    Intensive care unit stay is measured in hours.

    Measured: Up to 5 years

  52. Organ complications

    Organ complications are recorded in hospital records

    Measured: Up to 5 years

  53. Hospital discharge criteria

    Discharge criteria are measured at hospital discharge by Post Anesthetic Discharge Scoring System (PADS) Score

    Measured: Up to 5 years

  54. Mortality

    Mortality rate is measured after 1,2,3,4 and 5 years

    Measured: Up to 5 years

  55. Study data

    Identification of study data with a high impact on delirium from the study databases

    Measured: Up to 5 years

  56. 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

  57. 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.

  1. First posted22 Jun 2023
  2. Study start23 May 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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