Postoperative Delirium After Kidney Transplantation | NCT05887076

Studies
Postoperative Delirium After Kidney Transplantation

NCT05887076

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Oct 18, 2024Actual

Enrollment

362Actual

Phase

Not provided

Conditions

Post-operative Delirium

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2023Actual

Primary Completion Date

Dec 19, 2023Actual

Completion Date

Dec 19, 2023Actual

First Submitted Date

May 24, 2023

First Submission Date that Met QC Criteria

May 24, 2023

First Posted Date

Jun 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2024

Last Update Posted Date

Oct 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, Head of the Department of Anaesthesiology and Intensive Care Medicine CCM/CVK, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

362Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia Spies, MD, Prof.	Charite University, Berlin, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology and Intensive Care Medicine CCM, Charite - Universitätsmedizin		Berlin		10117	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided