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Clinical Trials/NCT05913531
NCT05913531
Recruiting
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country5,000 target enrollmentMay 23, 2023
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Charite University, Berlin, Germany
Enrollment
5000
Locations
1
Primary Endpoint
Delirium
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2023
End Date
December 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine CCM/CVK/CBF, Charité - University Berlin

Charite University, Berlin, Germany

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

  • Not provided

Outcomes

Primary Outcomes

Delirium

Time Frame: Up to 5 years

Validated delirium scoring (points, duration and severity)

Secondary Outcomes

  • Socioeconomic information 2(Up to 5 years)
  • Socioeconomic information 3(Up to 5 years)
  • Lifestyle risks 1(Up to 5 years)
  • Lifestyle risks 3(Up to 5 years)
  • Depression 2(Up to 5 years)
  • Anxiety scales 1(Up to 5 years)
  • Nutritional status 1(Up to 5 years)
  • Nutritional status 4(Up to 5 years)
  • Type of concomitant medication(Up to 5 years)
  • Socioeconomic information 1(Up to 5 years)
  • Quality of life - relatives(Up to 5 years)
  • Quality of life - self 1(Up to 5 years)
  • Depression 1(Up to 5 years)
  • Duration of operation(Up to 5 years)
  • Length of hospital stay(Up to 5 years)
  • Study data(Up to 5 years)
  • Sedation scales(Up to 5 years)
  • Frailty(Up to 5 years)
  • Comorbidities(Up to 5 years)
  • Charlson comorbidity index(Up to 5 years)
  • Lifestyle risks 4(Up to 5 years)
  • Functional impairment (ADL) 2(Up to 5 years)
  • Anxiety scale 2(Up to 5 years)
  • Anticholinergic Load(Up to 5 years)
  • Nutritional status 5(Up to 5 years)
  • Nutritional status 7(Up to 5 years)
  • Number of participants with changes in laboratory values 4(Up to 5 years)
  • Organ complications(Up to 5 years)
  • Functional impairment (IADL) 1(Up to 5 years)
  • Lifestyle risks 2(Up to 5 years)
  • Level of education(Up to 5 years)
  • Pain(Up to 5 years)
  • Nutritional status 9(Up to 5 years)
  • Quality of life - self 2(Up to 5 years)
  • Quality of life - self 3(Up to 5 years)
  • Depression 3(Up to 5 years)
  • Depression 4(Up to 5 years)
  • Nutritional status 2(Up to 5 years)
  • Nutritional status 3(Up to 5 years)
  • Nutritional status 6(Up to 5 years)
  • Nutritional status 8(Up to 5 years)
  • Mobility 1(Up to 5 years)
  • Number of participants with changes in laboratory values 1(Up to 5 years)
  • Number of participants with changes in laboratory values 2(Up to 5 years)
  • Type of operation(Up to 5 years)
  • Duration of anesthesia(Up to 5 years)
  • Intensive care unit stay(Up to 5 years)
  • Mortality(Up to 5 years)
  • Nutritional status 10(Up to 5 years)
  • Mobility 2(Up to 5 years)
  • Hospital discharge criteria(Up to 5 years)
  • Sleeping items(Up to 5 years)
  • Circadian rhythm variables(Up to 5 years)
  • Number of participants with changes in laboratory values 3(Up to 5 years)
  • Depth of sedation(Up to 5 years)
  • Type of anesthesia(Up to 5 years)

Study Sites (1)

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