NCT05887076

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 24, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2023

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

May 24, 2023

Last Update Submit

October 17, 2024

Conditions

Post-operative Delirium

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

    Incidence of delirium is recorded from validated delirium scores.

    2015 - 2019

Secondary Outcomes (11)

  • Duration of delirium

    2015 - 2019

  • Severity of delirium

    2015 - 2019

  • Intraoperative parameter

    2015 - 2019

  • Anesthesia

    2015 - 2019

  • Anesthesiological parameters

    2015 - 2019

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete data records of the parameters to be determined
  • Underage Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anaesthesiology and Intensive Care Medicine CCM, Charite - Universitätsmedizin

Berlin, 10117, Germany

Location

Medical Clinic with a focus on Nephrology and Internal Intensive Care Medicine

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

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 Anaesthesiology and Intensive Care Medicine CCM/CVK

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 2, 2023

Study Start

May 24, 2023

Primary Completion

December 19, 2023

Study Completion

December 19, 2023

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)