NCT_ID: NCT05887076
Clinical Trial Link
Brief Summaries
| Sequence: | 30735603 |
| Description | 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). |
Studies
| Study First Submitted Date | 2023-05-24 |
| Study First Posted Date | 2023-06-02 |
| Last Update Posted Date | 2023-06-05 |
| Start Month Year | May 24, 2023 |
| Primary Completion Month Year | December 2023 |
| Verification Month Year | June 2023 |
| Verification Date | 2023-06-30 |
| Last Update Posted Date | 2023-06-05 |
Detailed Descriptions
| Sequence: | 20701576 |
| 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. |
Facilities
| Sequence: | 199843031 | Sequence: | 199843032 |
| Status | Recruiting | Status | Recruiting |
| Name | Department of Anaesthesiology and Intensive Care Medicine CCM, Charite – Universitätsmedizin | Name | Medical Clinic with a focus on Nephrology and Internal Intensive Care Medicine |
| City | Berlin | City | Berlin |
| Zip | 10117 | Zip | 10117 |
| Country | Germany | Country | Germany |
Facility Contacts
| Sequence: | 28079662 | Sequence: | 28079663 |
| Facility Id | 199843031 | Facility Id | 199843032 |
| Contact Type | primary | Contact Type | primary |
| Name | Claudia Spies, MD Prof. | Name | Klemens Budde, MD, Prof. |
| claudia.spies@charite.de | |||
| Phone | +49 30 531 012 | ||
Facility Investigators
| Sequence: | 18313786 | Sequence: | 18313787 | Sequence: | 18313788 |
| Facility Id | 199843031 | Facility Id | 199843031 | Facility Id | 199843031 |
| Role | Principal Investigator | Role | Sub-Investigator | Role | Sub-Investigator |
| Name | Claudia Spies, MD, Prof. | Name | Anika Müller, MD | Name | Ferenc Fetyko, MD |
Conditions
| Sequence: | 52116183 |
| Name | Post-operative Delirium |
| Downcase Name | post-operative delirium |
Id Information
| Sequence: | 40116278 |
| Id Source | org_study_id |
| Id Value | PODNTX |
Countries
| Sequence: | 42520103 |
| Name | Germany |
| Removed | False |
Design Outcomes
| Sequence: | 177185270 | Sequence: | 177185271 | Sequence: | 177185272 | Sequence: | 177185273 | Sequence: | 177185274 | Sequence: | 177185275 | Sequence: | 177185276 | Sequence: | 177185277 | Sequence: | 177185278 | Sequence: | 177185279 | Sequence: | 177185280 | Sequence: | 177185281 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Incidence of delirium | Measure | Duration of delirium | Measure | Severity of delirium | Measure | Intraoperative parameter | Measure | Anesthesia | Measure | Anesthesiological parameters | Measure | Immunosupressive therapy | Measure | Delirium treatment | Measure | Pain teatment | Measure | Intensive care unit stay | Measure | Hospital stay | Measure | Mortality |
| Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 | Time Frame | 2015 – 2019 |
| Description | Incidence of delirium is recorded from validated delirium scores. | Description | Duration of delirium is recorded in days. | Description | Severity of delirium is recorded from validated delirium scores. | Description | Intraoperative parameter are recorded from patients with delirium. | Description | Anesthesia is recorded from patient files of patients with delirium. | Description | Anesthesiological parameters are recorded from patient files of patients with delirium. | Description | Immunosupressive therapy is recorded in patients with delirium. | Description | Delirium treatment is recorded peri-operatively. | Description | Pain treatment is recorded peri-operatively. | Description | Length of intensive care unit stay is measured in days. | Description | Length of hospital stay is measured in days. | Description | Mortality is measured within the hospital |
Browse Conditions
| Sequence: | 193273136 | Sequence: | 193273137 | Sequence: | 193273138 | Sequence: | 193273139 | Sequence: | 193273140 | Sequence: | 193273141 | Sequence: | 193273142 | Sequence: | 193273143 | Sequence: | 193273144 | Sequence: | 193273145 |
| Mesh Term | Delirium | Mesh Term | Emergence Delirium | Mesh Term | Confusion | Mesh Term | Neurobehavioral Manifestations | Mesh Term | Neurologic Manifestations | Mesh Term | Nervous System Diseases | Mesh Term | Neurocognitive Disorders | Mesh Term | Mental Disorders | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes |
| Downcase Mesh Term | delirium | Downcase Mesh Term | emergence delirium | Downcase Mesh Term | confusion | Downcase Mesh Term | neurobehavioral manifestations | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neurocognitive disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48269411 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Charite University, Berlin, Germany |
Overall Officials
| Sequence: | 29254390 |
| Role | Study Director |
| Name | Claudia Spies, MD, Prof. |
| Affiliation | Charite University, Berlin, Germany |
Central Contacts
| Sequence: | 11996573 |
| Contact Type | primary |
| Name | Claudia Spies, MD, Prof. |
| Phone | +49 30 450 55 11 02 |
| claudia.spies@charite.de | |
| Role | Contact |
Eligibilities
| Sequence: | 30734384 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Population | Male and female patients 18 years and older who underwent kidney transplantation |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254009673 |
| Number Of Facilities | 2 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 11 |
Designs
| Sequence: | 30480753 |
| Observational Model | Cohort |
| Time Perspective | Retrospective |
Responsible Parties
| Sequence: | 28847104 |
| Responsible Party Type | Principal Investigator |
| Name | Claudia Spies |
| Title | Head of the Department of Anaesthesiology and Intensive Care Medicine CCM/CVK |
| Affiliation | Charite University, Berlin, Germany |