Postoperative Delirium After Kidney Transplantation

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).

Study Overview

• Status: Completed
• Conditions: Post-operative Delirium

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Department of Anaesthesiology and Intensive Care Medicine CCM, Charite - Universitätsmedizin
  • Berlin, Germany, 10117
    • Medical Clinic with a focus on Nephrology and Internal Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Male and female patients 18 years and older who underwent kidney transplantation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delirium	Incidence of delirium is recorded from validated delirium scores.	2015 - 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of delirium	Duration of delirium is recorded in days.	2015 - 2019
Severity of delirium	Severity of delirium is recorded from validated delirium scores.	2015 - 2019
Intraoperative parameter	Intraoperative parameter are recorded from patients with delirium.	2015 - 2019
Anesthesia	Anesthesia is recorded from patient files of patients with delirium.	2015 - 2019
Anesthesiological parameters	Anesthesiological parameters are recorded from patient files of patients with delirium.	2015 - 2019
Immunosupressive therapy	Immunosupressive therapy is recorded in patients with delirium.	2015 - 2019
Delirium treatment	Delirium treatment is recorded peri-operatively.	2015 - 2019
Pain teatment	Pain treatment is recorded peri-operatively.	2015 - 2019
Intensive care unit stay	Length of intensive care unit stay is measured in days.	2015 - 2019
Hospital stay	Length of hospital stay is measured in days.	2015 - 2019
Mortality	Mortality is measured within the hospital	2015 - 2019

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: PODNTX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No