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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05887076
Other study ID # PODNTX
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 24, 2023
Est. completion date December 2023

Study information

Verified date June 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
Health authority
Study type Observational

Clinical Trial Summary

This project is a retrospective evaluation of the routine data of patients who underwent a kidney transplant at the Charité Campus Mitte between January 2015 and December 2019 (until the corona pandemic).


Description:

Post-anesthetic complications such as delirium can occur in patients after kidney transplantation. We would therefore like to characterize pathophysiological changes after transplantation of the kidneys and, if necessary, gain diagnostic and therapeutic knowledge. The purpose is to study postoperative delirium after kidney transplantation.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients 18 years and older who underwent kidney transplantation and who were admitted to Post-intensive care unit or to an Intensive care unit at the Campus Charité Mitte Exclusion Criteria: - Incomplete data records of the parameters to be determined - Underage Patients

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Anaesthesiology and Intensive Care Medicine CCM, Charite - Universitätsmedizin Berlin
Germany Medical Clinic with a focus on Nephrology and Internal Intensive Care Medicine 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
Primary Incidence of delirium Incidence of delirium is recorded from validated delirium scores. 2015 - 2019
Secondary Duration of delirium Duration of delirium is recorded in days. 2015 - 2019
Secondary Severity of delirium Severity of delirium is recorded from validated delirium scores. 2015 - 2019
Secondary Intraoperative parameter Intraoperative parameter are recorded from patients with delirium. 2015 - 2019
Secondary Anesthesia Anesthesia is recorded from patient files of patients with delirium. 2015 - 2019
Secondary Anesthesiological parameters Anesthesiological parameters are recorded from patient files of patients with delirium. 2015 - 2019
Secondary Immunosupressive therapy Immunosupressive therapy is recorded in patients with delirium. 2015 - 2019
Secondary Delirium treatment Delirium treatment is recorded peri-operatively. 2015 - 2019
Secondary Pain teatment Pain treatment is recorded peri-operatively. 2015 - 2019
Secondary Intensive care unit stay Length of intensive care unit stay is measured in days. 2015 - 2019
Secondary Hospital stay Length of hospital stay is measured in days. 2015 - 2019
Secondary Mortality Mortality is measured within the hospital 2015 - 2019
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