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

Delirium Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913531
• Other study ID #: Retro-Delirium
• Status: Recruiting
• Start date: May 23, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD Prof.
• Phone: +49 30 450 55 11 02
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Germany	Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parameter of cognition	Cognitive functioning will be measured with a battery of computerized neuropsychological tests.	Up to 5 years
Other	Parameter of cognition	Cognitive functioning will be measured with a battery of non-computerized neuropsychological tests.	Up to 5 years
Other	Demographic data	Demographic data are documented in the hospital records.	Up to 5 years
Primary	Delirium	Validated delirium scoring (points, duration and severity)	Up to 5 years
Secondary	Sedation scales	Sedation is measured by the Richmond Agitation Sedation Scale	Up to 5 years
Secondary	Socioeconomic information 1	Soci-economic information is collected by FIMA	Up to 5 years
Secondary	Socioeconomic information 2	Soci-economic information is collected by the Nikolaus-score (social situation), 1. Subscale	Up to 5 years
Secondary	Socioeconomic information 3	Soci-economic information is collected by items on socioeconomic status from the Federal Health Survey of 1998	Up to 5 years
Secondary	Comorbidities	Comorbidities are new diagnoses from hospital records.	Up to 5 years
Secondary	Charlson comorbidity index	Comorbidity scores	Up to 5 years
Secondary	Lifestyle risks 1	Consumption of alcohol is measured by AUDIT (Alcohol Use Disorders Identification Tests)	Up to 5 years
Secondary	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	Up to 5 years
Secondary	Lifestyle risks 3	Consumption of nicotine is measured by Smocking Pack Years (SPY)	Up to 5 years
Secondary	Lifestyle risks 4	Previous consumption of nicotine is measured by History of Smoking.	Up to 5 years
Secondary	Level of education	Level of education is measured by ISCED (International Standard Classification of Education)	Up to 5 years
Secondary	Quality of life - relatives	Quality of life is measured by CarerQoL	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	Quality of life - self 3	Quality of life is measured by SF-12 (Short form health survey)	Up to 5 years
Secondary	Functional impairment (IADL) 1	Instrumental Activities of Daily Living (IADLs) < 8	Up to 5 years
Secondary	Functional impairment (ADL) 2	Activities of Daily Living (ADLs) < 100	Up to 5 years
Secondary	Depression 1	Depression 1 is measured by PHQ-8 (Patient Health Questionnaire depression scale)	Up to 5 years
Secondary	Depression 2	Depression 2 is measured by GDS (Geriatric Depression Scale)	Up to 5 years
Secondary	Depression 3	Depression 3 is measured by HADS (Hospital Anxiety and Depression Scale)	Up to 5 years
Secondary	Depression 4	Depression 4 is measured by CDS (Cornel Depression Scale)	Up to 5 years
Secondary	Anxiety scales 1	Anxiety is measured by GAD-7 (Generalized Anxiety Disorder 7)	Up to 5 years
Secondary	Anxiety scale 2	Anxiety 2 is measured by FAS (Faces Anxiety Scale)	Up to 5 years
Secondary	Anxiety scale 2	Anxiety 2 is measured by GAD-7	Up to 5 years
Secondary	Pain	Pain is measured by numeric pain scales (minimum = 0, maximum = 10).	Up to 5 years
Secondary	Type of concomitant medication	The medication administered during the hospital stay is documented.	Up to 5 years
Secondary	Anticholinergic Load	Measured by anticholinergic drug scale	Up to 5 years
Secondary	Frailty	Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.	Up to 5 years
Secondary	Nutritional status 1	Nutritional status 1 is measured by calf circumference	Up to 5 years
Secondary	Nutritional status 2	Nutritional status 2 is measured by arm circumference	Up to 5 years
Secondary	Nutritional status 3	Nutritional status 3 is measured by changes in weight	Up to 5 years
Secondary	Nutritional status 4	Nutritional status 4 is measured by changes in body mass index	Up to 5 years
Secondary	Nutritional status 5	Nutritional status 5 is measured by previous weight history (3 months)	Up to 5 years
Secondary	Nutritional status 6	Nutritional status 6 is measured by Medi-Score	Up to 5 years
Secondary	Nutritional status 7	Nutritional status 7 is measured by MNA-SF	Up to 5 years
Secondary	Nutritional status 8	Nutritional status 8 is measured by Sarcopenia	Up to 5 years
Secondary	Nutritional status 9	Nutritional status 9 is measured by Nutritional Risk Screening (NRS 2002)	Up to 5 years
Secondary	Nutritional status 10	Nutritional status 10 is measured by AKE Screening	Up to 5 years
Secondary	Mobility 1	Mobility 1 is measured with the Timed up and Go	Up to 5 years
Secondary	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).	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	Number of participants with changes in laboratory values 2	Laboratory results in the hospital from serum samples	Up to 5 years
Secondary	Number of participants with changes in laboratory values 3	Laboratory results in the hospital from urine samples	Up to 5 years
Secondary	Number of participants with changes in laboratory values 4	Laboratory results in the hospital from liquor samples	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	Type of operation	Type of operation is measured by OPS-Code	Up to 5 years
Secondary	Duration of operation	Type of operation is measured in minutes	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	Duration of anesthesia	Duration of anesthesia is measured in minutes.	Up to 5 years
Secondary	Length of hospital stay	Hospital stay is measured in days.	Up to 5 years
Secondary	Intensive care unit stay	Intensive care unit stay is measured in hours.	Up to 5 years
Secondary	Organ complications	Organ complications are recorded in hospital records	Up to 5 years
Secondary	Hospital discharge criteria	Discharge criteria are measured at hospital discharge by Post Anesthetic Discharge Scoring System (PADS) Score	Up to 5 years
Secondary	Mortality	Mortality rate is measured after 1,2,3,4 and 5 years	Up to 5 years
Secondary	Study data	Identification of study data with a high impact on delirium from the study databases	Up to 5 years
Secondary	Sleeping items	Questions measuring personal satisfaction with sleep quality and duration As measured by questions measuring personal satisfaction with sleep quality and duration	Up to 5 years
Secondary	Circadian rhythm variables	Items measuring circadian rhythm variables e.g. Zeitgebers	Up to 5 years