NCT04670744

Brief Summary

The availability of electronic documentation systems in patient care means that large amounts of clinical routine data are available from which conclusions can be drawn for improving patient care. Compared to conventional research approaches, a data science-oriented approach offers the possibility of identifying patterns in routine data ("pattern recognition") that are relevant for patient-centered outcomes. Numerous projects and sub-projects can be evaluated from this data set.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Dec 2020

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Dec 2020Dec 2030

Study Start

First participant enrolled

December 3, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

10.1 years

First QC Date

December 10, 2020

Last Update Submit

June 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mortality I

    Mortality is measured by inhouse mortality.

    01.01.2016-30.04.2026

  • Mortality II

    Mortality is measured by long-term mortality (1 year)

    01.01.2016-30.04.2026

Secondary Outcomes (4)

  • Morbidity

    01.01.2016-30.04.2026

  • Accounting data

    01.01.2016-30.04.2026

  • Functional status

    01.01.2016-30.04.2026

  • Post Intensive Care Syndrome (PICS)

    01.01.2016-30.04.2026

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

At the department for anesthesiology with a focus on operative intensive care medicine, approximately 60,000 anaesthesias are performed annually. The data sets of documentation systems used in this context date back approximately to the year 2016 and are to be considered for the development of data science-based models depending on selected QI or SOPs.

You may qualify if:

  • Age: 0 to 120 years
  • Gender: female, male, diverse
  • Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Department of Anesthesiology and Intensive Care Medicine, CCM/CVK/CBF) since 2016

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

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 Operative Intensive Care Medicine (CCM/CVK)

Study Record Dates

First Submitted

December 10, 2020

First Posted

December 17, 2020

Study Start

December 3, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations