Post-operative DeliriumNCT05887076
Postoperative Delirium After Kidney Transplantation
An observational study of Post-operative Delirium, run by Charite University, Berlin, Germany at 2 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Delirium
- How many people
- 362 participants
- Where
- 2 sitesGermany
- Study dates
- 24 May 2023to 19 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients 18 years and older who underwent kidney transplantation
Who may be able to join
- 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
Who cannot join
- Incomplete data records of the parameters to be determined
- Underage Patients
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Anaesthesiology and Intensive Care Medicine CCM, Charite - Universitätsmedizin
Berlin, 10117
Medical Clinic with a focus on Nephrology and Internal Intensive Care Medicine
Berlin, 10117
About this study
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).
Read the 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.
- Conditions
- Post-operative Delirium
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Incidence of delirium is recorded from validated delirium scores.
Measured: 2015 - 2019
Secondary outcomes (11)
Duration of delirium
Duration of delirium is recorded in days.
Measured: 2015 - 2019
Severity of delirium
Severity of delirium is recorded from validated delirium scores.
Measured: 2015 - 2019
Intraoperative parameter
Intraoperative parameter are recorded from patients with delirium.
Measured: 2015 - 2019
Anesthesia
Anesthesia is recorded from patient files of patients with delirium.
Measured: 2015 - 2019
Anesthesiological parameters
Anesthesiological parameters are recorded from patient files of patients with delirium.
Measured: 2015 - 2019
Immunosupressive therapy
Immunosupressive therapy is recorded in patients with delirium.
Measured: 2015 - 2019
Delirium treatment
Delirium treatment is recorded peri-operatively.
Measured: 2015 - 2019
Pain teatment
Pain treatment is recorded peri-operatively.
Measured: 2015 - 2019
Intensive care unit stay
Length of intensive care unit stay is measured in days.
Measured: 2015 - 2019
Hospital stay
Length of hospital stay is measured in days.
Measured: 2015 - 2019
Mortality
Mortality is measured within the hospital
Measured: 2015 - 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start24 May 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887076
- Sponsor's protocol ID
- PODNTX
- Status last verified
- Oct 2024
- First submitted
- 24 May 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05887076
- Acronym / sponsor ID
- PODNTX
- Conditions
- Post-operative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients 18 years and older who underwent kidney transplantation
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Incomplete data records of the parameters to be determined
- Underage Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of delirium
Time frame: 2015 - 2019
Incidence of delirium is recorded from validated delirium scores.
11 secondary outcomes
Duration of delirium
Time frame: 2015 - 2019
Severity of delirium
Time frame: 2015 - 2019
Intraoperative parameter
Time frame: 2015 - 2019
Anesthesia
Time frame: 2015 - 2019
Anesthesiological parameters
Time frame: 2015 - 2019
Immunosupressive therapy
Time frame: 2015 - 2019
Delirium treatment
Time frame: 2015 - 2019
Pain teatment
Time frame: 2015 - 2019
Intensive care unit stay
Time frame: 2015 - 2019
Hospital stay
Time frame: 2015 - 2019
Mortality
Time frame: 2015 - 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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Lactium Premedication to Prevent Emergence Agitation
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Delirium, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: 2015 - 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.