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NCT Number: NCT05913531

Retrospective Evaluation of Delirium Data From Previous Study Patients for Studies at the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin

Berlin, 13355, Germany

Location status: Recruiting

Location contact

Claudia Spies, MD, Prof.

CONTACT

[email protected]

+49 30 450 55 11 02

Claudia Spies, MD, Prof.

PRINCIPAL_INVESTIGATOR

Friedrich Borchers, MD

SUB_INVESTIGATOR

Henning Krampe, PD

SUB_INVESTIGATOR

Kathrin Scholtz

SUB_INVESTIGATOR

Luzy Grüner

SUB_INVESTIGATOR

Maria Heinrich, MD

SUB_INVESTIGATOR

Sascha Treskatsch, MD, Prof.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Delirium

    Time frame: Up to 5 years

    Validated delirium scoring (points, duration and severity)

Secondary outcomes

  1. Sedation scales

    Time frame: Up to 5 years

    Sedation is measured by the Richmond Agitation Sedation Scale

  2. Socioeconomic information 1

    Time frame: Up to 5 years

    Soci-economic information is collected by FIMA

  3. Socioeconomic information 2

    Time frame: Up to 5 years

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

  4. Socioeconomic information 3

    Time frame: Up to 5 years

    Soci-economic information is collected by items on socioeconomic status from the Federal Health Survey of 1998

  5. Comorbidities

    Time frame: Up to 5 years

    Comorbidities are new diagnoses from hospital records.

  6. Charlson comorbidity index

    Time frame: Up to 5 years

    Comorbidity scores

  7. Lifestyle risks 1

    Time frame: Up to 5 years

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

  8. Lifestyle risks 2

    Time frame: Up to 5 years

    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

  9. Lifestyle risks 3

    Time frame: Up to 5 years

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

  10. Lifestyle risks 4

    Time frame: Up to 5 years

    Previous consumption of nicotine is measured by History of Smoking.

  11. Level of education

    Time frame: Up to 5 years

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

  12. Quality of life - relatives

    Time frame: Up to 5 years

    Quality of life is measured by CarerQoL

  13. Quality of life - self 1

    Time frame: Up to 5 years

    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.

  14. Quality of life - self 2

    Time frame: Up to 5 years

    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.

  15. Quality of life - self 3

    Time frame: Up to 5 years

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

  16. Functional impairment (IADL) 1

    Time frame: Up to 5 years

    Instrumental Activities of Daily Living (IADLs) < 8

  17. Functional impairment (ADL) 2

    Time frame: Up to 5 years

    Activities of Daily Living (ADLs) < 100

  18. Depression 1

    Time frame: Up to 5 years

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

  19. Depression 2

    Time frame: Up to 5 years

    Depression 2 is measured by GDS (Geriatric Depression Scale)

  20. Depression 3

    Time frame: Up to 5 years

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

  21. Depression 4

    Time frame: Up to 5 years

    Depression 4 is measured by CDS (Cornel Depression Scale)

  22. Anxiety scales 1

    Time frame: Up to 5 years

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

  23. Anxiety scale 2

    Time frame: Up to 5 years

    Anxiety 2 is measured by FAS (Faces Anxiety Scale)

  24. Anxiety scale 2

    Time frame: Up to 5 years

    Anxiety 2 is measured by GAD-7

  25. Pain

    Time frame: Up to 5 years

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

  26. Type of concomitant medication

    Time frame: Up to 5 years

    The medication administered during the hospital stay is documented.

  27. Anticholinergic Load

    Time frame: Up to 5 years

    Measured by anticholinergic drug scale

  28. Frailty

    Time frame: Up to 5 years

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

  29. Nutritional status 1

    Time frame: Up to 5 years

    Nutritional status 1 is measured by calf circumference

  30. Nutritional status 2

    Time frame: Up to 5 years

    Nutritional status 2 is measured by arm circumference

  31. Nutritional status 3

    Time frame: Up to 5 years

    Nutritional status 3 is measured by changes in weight

  32. Nutritional status 4

    Time frame: Up to 5 years

    Nutritional status 4 is measured by changes in body mass index

  33. Nutritional status 5

    Time frame: Up to 5 years

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

  34. Nutritional status 6

    Time frame: Up to 5 years

    Nutritional status 6 is measured by Medi-Score

  35. Nutritional status 7

    Time frame: Up to 5 years

    Nutritional status 7 is measured by MNA-SF

  36. Nutritional status 8

    Time frame: Up to 5 years

    Nutritional status 8 is measured by Sarcopenia

  37. Nutritional status 9

    Time frame: Up to 5 years

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

  38. Nutritional status 10

    Time frame: Up to 5 years

    Nutritional status 10 is measured by AKE Screening

  39. Mobility 1

    Time frame: Up to 5 years

    Mobility 1 is measured with the Timed up and Go

  40. Mobility 2

    Time frame: Up to 5 years

    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).

  41. Number of participants with changes in laboratory values 1

    Time frame: Up to 5 years

    Laboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.

  42. Number of participants with changes in laboratory values 2

    Time frame: Up to 5 years

    Laboratory results in the hospital from serum samples

  43. Number of participants with changes in laboratory values 3

    Time frame: Up to 5 years

    Laboratory results in the hospital from urine samples

  44. Number of participants with changes in laboratory values 4

    Time frame: Up to 5 years

    Laboratory results in the hospital from liquor samples

  45. Depth of sedation

    Time frame: Up to 5 years

    The sedation was measured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.

  46. Type of operation

    Time frame: Up to 5 years

    Type of operation is measured by OPS-Code

  47. Duration of operation

    Time frame: Up to 5 years

    Type of operation is measured in minutes

  48. Type of anesthesia

    Time frame: Up to 5 years

    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.

  49. Duration of anesthesia

    Time frame: Up to 5 years

    Duration of anesthesia is measured in minutes.

  50. Length of hospital stay

    Time frame: Up to 5 years

    Hospital stay is measured in days.

  51. Intensive care unit stay

    Time frame: Up to 5 years

    Intensive care unit stay is measured in hours.

  52. Organ complications

    Time frame: Up to 5 years

    Organ complications are recorded in hospital records

  53. Hospital discharge criteria

    Time frame: Up to 5 years

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

  54. Mortality

    Time frame: Up to 5 years

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

  55. Study data

    Time frame: Up to 5 years

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

  56. Sleeping items

    Time frame: Up to 5 years

    Questions measuring personal satisfaction with sleep quality and duration As measured by questions measuring personal satisfaction with sleep quality and duration

  57. Circadian rhythm variables

    Time frame: Up to 5 years

    Items measuring circadian rhythm variables e.g. Zeitgebers

Other outcomes

  1. Parameter of cognition

    Time frame: Up to 5 years

    Cognitive functioning will be measured with a battery of computerized neuropsychological tests.

  2. Parameter of cognition

    Time frame: Up to 5 years

    Cognitive functioning will be measured with a battery of non-computerized neuropsychological tests.

  3. Demographic data

    Time frame: Up to 5 years

    Demographic data are documented in the hospital records.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Spies, MD Prof.

CONTACT

[email protected]

+49 30 450 55 11 02

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Feb 4, 2025

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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