Clinical trial NCT05913531: Retrospective Evaluation of Delirium Data From Previous Study Patients for Studies at the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF

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.


Eligibility criteria: 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

Primary outcomes:
measure: Delirium
timeFrame: Up to 5 years
Secondary outcomes:
measure: Sedation scales
timeFrame: Up to 5 years
measure: Socioeconomic information 1
timeFrame: Up to 5 years
measure: Socioeconomic information 2
timeFrame: Up to 5 years
measure: Socioeconomic information 3
timeFrame: Up to 5 years
measure: Comorbidities
timeFrame: Up to 5 years
measure: Charlson comorbidity index
timeFrame: Up to 5 years
measure: Lifestyle risks 1
timeFrame: Up to 5 years
measure: Lifestyle risks 2
timeFrame: Up to 5 years
measure: Lifestyle risks 3
timeFrame: Up to 5 years
measure: Lifestyle risks 4
timeFrame: Up to 5 years
measure: Level of education
timeFrame: Up to 5 years
measure: Quality of life - relatives
timeFrame: Up to 5 years
measure: Quality of life - self 1
timeFrame: Up to 5 years
measure: Quality of life - self 2
timeFrame: Up to 5 years
measure: Quality of life - self 3
timeFrame: Up to 5 years
measure: Functional impairment (IADL) 1
timeFrame: Up to 5 years
measure: Functional impairment (ADL) 2
timeFrame: Up to 5 years
measure: Depression 1
timeFrame: Up to 5 years
measure: Depression 2
timeFrame: Up to 5 years
measure: Depression 3
timeFrame: Up to 5 years
measure: Depression 4
timeFrame: Up to 5 years
measure: Anxiety scales 1
timeFrame: Up to 5 years
measure: Anxiety scale 2
timeFrame: Up to 5 years
measure: Anxiety scale 2
timeFrame: Up to 5 years
measure: Pain
timeFrame: Up to 5 years
measure: Type of concomitant medication
timeFrame: Up to 5 years
measure: Anticholinergic Load
timeFrame: Up to 5 years
measure: Frailty
timeFrame: Up to 5 years
measure: Nutritional status 1
timeFrame: Up to 5 years
measure: Nutritional status 2
timeFrame: Up to 5 years
measure: Nutritional status 3
timeFrame: Up to 5 years
measure: Nutritional status 4
timeFrame: Up to 5 years
measure: Nutritional status 5
timeFrame: Up to 5 years
measure: Nutritional status 6
timeFrame: Up to 5 years
measure: Nutritional status 7
timeFrame: Up to 5 years
measure: Nutritional status 8
timeFrame: Up to 5 years
measure: Nutritional status 9
timeFrame: Up to 5 years
measure: Nutritional status 10
timeFrame: Up to 5 years
measure: Mobility 1
timeFrame: Up to 5 years
measure: Mobility 2
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 1
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 2
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 3
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 4
timeFrame: Up to 5 years
measure: Depth of sedation
timeFrame: Up to 5 years
measure: Type of operation
timeFrame: Up to 5 years
measure: Duration of operation
timeFrame: Up to 5 years
measure: Type of anesthesia
timeFrame: Up to 5 years
measure: Duration of anesthesia
timeFrame: Up to 5 years
measure: Length of hospital stay
timeFrame: Up to 5 years
measure: Intensive care unit stay
timeFrame: Up to 5 years
measure: Organ complications
timeFrame: Up to 5 years
measure: Hospital discharge criteria
timeFrame: Up to 5 years
measure: Mortality
timeFrame: Up to 5 years
measure: Study data
timeFrame: Up to 5 years
measure: Sleeping items
timeFrame: Up to 5 years
measure: Circadian rhythm variables
timeFrame: Up to 5 years
Other outcomes:
measure: Parameter of cognition
timeFrame: Up to 5 years
measure: Parameter of cognition
timeFrame: Up to 5 years
measure: Demographic data
timeFrame: Up to 5 years
Locations:
city: Berlin
country: Germany
facility: Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: