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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05913531
Enrollment
5000
Registered
2023-06-22
Start date
2023-05-23
Completion date
2026-12-31
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Brief 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. 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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DeliriumUp to 5 yearsValidated delirium scoring (points, duration and severity)

Secondary

MeasureTime frameDescription
Organ complicationsUp to 5 yearsOrgan complications are recorded in hospital records
Charlson comorbidity indexUp to 5 yearsComorbidity scores
Duration of anesthesiaUp to 5 yearsDuration of anesthesia is measured in minutes.
Sleeping itemsUp to 5 yearsQuestions measuring personal satisfaction with sleep quality and duration As measured by questions measuring personal satisfaction with sleep quality and duration
Circadian rhythm variablesUp to 5 yearsItems measuring circadian rhythm variables e.g. Zeitgebers
Socioeconomic information 2Up to 5 yearsSoci-economic information is collected by the Nikolaus-score (social situation), 1. Subscale
Socioeconomic information 3Up to 5 yearsSoci-economic information is collected by items on socioeconomic status from the Federal Health Survey of 1998
ComorbiditiesUp to 5 yearsComorbidities are new diagnoses from hospital records.
Sedation scalesUp to 5 yearsSedation is measured by the Richmond Agitation Sedation Scale
Socioeconomic information 1Up to 5 yearsSoci-economic information is collected by FIMA
Lifestyle risks 1Up to 5 yearsConsumption of alcohol is measured by AUDIT (Alcohol Use Disorders Identification Tests)
Lifestyle risks 2Up to 5 yearsConsumption 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
Lifestyle risks 3Up to 5 yearsConsumption of nicotine is measured by Smocking Pack Years (SPY)
Lifestyle risks 4Up to 5 yearsPrevious consumption of nicotine is measured by History of Smoking.
Level of educationUp to 5 yearsLevel of education is measured by ISCED (International Standard Classification of Education)
Quality of life - relativesUp to 5 yearsQuality of life is measured by CarerQoL
Quality of life - self 1Up to 5 yearsQuality 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.
Quality of life - self 2Up to 5 yearsQuality 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.
Quality of life - self 3Up to 5 yearsQuality of life is measured by SF-12 (Short form health survey)
Functional impairment (IADL) 1Up to 5 yearsInstrumental Activities of Daily Living (IADLs) \< 8
Functional impairment (ADL) 2Up to 5 yearsActivities of Daily Living (ADLs) \< 100
Depression 1Up to 5 yearsDepression 1 is measured by PHQ-8 (Patient Health Questionnaire depression scale)
Depression 2Up to 5 yearsDepression 2 is measured by GDS (Geriatric Depression Scale)
Depression 3Up to 5 yearsDepression 3 is measured by HADS (Hospital Anxiety and Depression Scale)
Depression 4Up to 5 yearsDepression 4 is measured by CDS (Cornel Depression Scale)
Anxiety scales 1Up to 5 yearsAnxiety is measured by GAD-7 (Generalized Anxiety Disorder 7)
Anxiety scale 2Up to 5 yearsAnxiety 2 is measured by FAS (Faces Anxiety Scale)
PainUp to 5 yearsPain is measured by numeric pain scales (minimum = 0, maximum = 10).
Type of concomitant medicationUp to 5 yearsThe medication administered during the hospital stay is documented.
Anticholinergic LoadUp to 5 yearsMeasured by anticholinergic drug scale
FrailtyUp to 5 yearsFrailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.
Nutritional status 1Up to 5 yearsNutritional status 1 is measured by calf circumference
Nutritional status 2Up to 5 yearsNutritional status 2 is measured by arm circumference
Nutritional status 3Up to 5 yearsNutritional status 3 is measured by changes in weight
Nutritional status 4Up to 5 yearsNutritional status 4 is measured by changes in body mass index
Nutritional status 5Up to 5 yearsNutritional status 5 is measured by previous weight history (3 months)
Nutritional status 6Up to 5 yearsNutritional status 6 is measured by Medi-Score
Nutritional status 7Up to 5 yearsNutritional status 7 is measured by MNA-SF
Nutritional status 8Up to 5 yearsNutritional status 8 is measured by Sarcopenia
Nutritional status 9Up to 5 yearsNutritional status 9 is measured by Nutritional Risk Screening (NRS 2002)
Nutritional status 10Up to 5 yearsNutritional status 10 is measured by AKE Screening
Mobility 1Up to 5 yearsMobility 1 is measured with the Timed up and Go
Mobility 2Up to 5 yearsMobility 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).
Number of participants with changes in laboratory values 1Up to 5 yearsLaboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.
Number of participants with changes in laboratory values 2Up to 5 yearsLaboratory results in the hospital from serum samples
Number of participants with changes in laboratory values 3Up to 5 yearsLaboratory results in the hospital from urine samples
Number of participants with changes in laboratory values 4Up to 5 yearsLaboratory results in the hospital from liquor samples
Depth of sedationUp to 5 yearsThe sedation was measured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.
Type of operationUp to 5 yearsType of operation is measured by OPS-Code
Duration of operationUp to 5 yearsType of operation is measured in minutes
Type of anesthesiaUp to 5 yearsThere 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.
Intensive care unit stayUp to 5 yearsIntensive care unit stay is measured in hours.
Length of hospital stayUp to 5 yearsHospital stay is measured in days.
Hospital discharge criteriaUp to 5 yearsDischarge criteria are measured at hospital discharge by Post Anesthetic Discharge Scoring System (PADS) Score
MortalityUp to 5 yearsMortality rate is measured after 1,2,3,4 and 5 years
Study dataUp to 5 yearsIdentification of study data with a high impact on delirium from the study databases

Other

MeasureTime frameDescription
Demographic dataUp to 5 yearsDemographic data are documented in the hospital records.
Parameter of cognitionUp to 5 yearsCognitive functioning will be measured with a battery of computerized neuropsychological tests.

Countries

Germany

Contacts

Primary ContactClaudia Spies, MD Prof.
claudia.spies@charite.de+49 30 450 55 11 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026