NCT05913531

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
May 2023Dec 2026

First Submitted

Initial submission to the registry

May 11, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

3.6 years

First QC Date

May 11, 2023

Last Update Submit

February 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Validated delirium scoring (points, duration and severity)

    Up to 5 years

Secondary Outcomes (57)

  • Sedation scales

    Up to 5 years

  • Socioeconomic information 1

    Up to 5 years

  • Socioeconomic information 2

    Up to 5 years

  • Socioeconomic information 3

    Up to 5 years

  • Comorbidities

    Up to 5 years

  • +52 more secondary outcomes

Other Outcomes (3)

  • Parameter of cognition

    Up to 5 years

  • Parameter of cognition

    Up to 5 years

  • Demographic data

    Up to 5 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, 13355, Germany

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Intensive Care Medicine CCM/CVK/CBF, Charité - University Berlin

Study Record Dates

First Submitted

May 11, 2023

First Posted

June 22, 2023

Study Start

May 23, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations