Postoperative Delirium (POD)GENECARDNCT07345403
GENECARD - the Use of Genetic, Epigenetic, Metabolomic, Proteomic and Microbiotic Markers, Image and Voice Biomarker Analyses, and Pre- and Intraoperative Clinical Data - to Predict Early Complications After Cardiac Surgery.
An observational study of Postoperative Delirium (POD) and Postoperative Bleeding, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Postoperative Bleeding, Acute Kidney Injury
- What is being tested?
- Multi-Omics Data and Clinical Data Collection
- How many people
- 3,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2026to 31 Dec 2029
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients undergoing elective cardiac surgery at a single center. Participants include men and women who consent to provide clinical data and biospecimens for analysis. Individuals under 18 years of age or with prior or planned organ or bone marrow transplantation are excluded.
Who may be able to join
- Adults (≥18 years old)
- Undergoing elective cardiac surgery
- Able and willing to provide informed consent
Who cannot join
- Age below 18 years
- Lack of informed consent
- Prior or planned solid organ transplantation
- Prior or planned bone marrow transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
University Clinical Centre Gdansk, Department of Anaesthesiology and Intensive Care
Gdansk, 80-952
Maciej Kowalik, MD, PhD, +48583493270, anestezjologia@uck.gda.pl
About this study
The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients.
The main questions it aims to answer are:
Read more
Which biological and clinical markers are associated with: new-onset atrial fibrillation (NOAF), acute kidney injury (AKI), postoperative delirium (POD), vasoplegia, postoperative bleeding and 30-day mortality? Can combining these markers improve early prediction of postoperative complications compared with current clinical risk scores?
Researchers will analyze a wide range of data collected before, during, and after cardiac surgery and compare patients who develop early complications with those who do not to identify risk factors and early biomarkers.
Participants will:
Provide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing.
Undergo standard preoperative and intraoperative imaging and clinical assessments.
Allow collection of clinical data related to postoperative outcomes (For some participants) have voice and video recordings performed to help identify early signs of postoperative delirium.
This study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.
Read the detailed description
Single-center, prospective, translational, observational cohort study designed to identify markers that predict early postoperative complications in adult patients undergoing elective cardiac surgery. The study will analyze genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, imaging, voice, and detailed clinical data collected before, during, and after surgery. Approximately 2,000-3,000 participants will be enrolled between 2026 and 2029.
Study Objectives
The main objective is to determine whether selected biological and clinical markers can predict early postoperative complications, including:
New-onset atrial fibrillation (NOAF), Acute kidney injury (AKI), Postoperative delirium (POD), Vasoplegia, Postoperative bleeding 30-day mortality.
The study will use current clinical definitions: NOAF per ESC guidelines, AKI per KDIGO criteria, and POD per DSM-V, as well as validated delirium scales such as CAM-ICU or DOSS. Postoperative bleeding will be defined as >1000 mL drainage in 24 hours or the need for surgical re-exploration.
Secondary outcomes include in-hospital mortality, 30-day mortality, duration of mechanical ventilation, ICU length of stay, and total postoperative hospital length of stay.
Participants
Eligible participants are adult men and women undergoing elective cardiac surgery who provide informed consent. Exclusion criteria are age <18 years, lack of consent, and prior or planned organ or bone marrow transplantation.
Data and Sample Collection
The study will collect a broad set of data and biological materials, including:
Clinical data: detailed medical history, epidemiologic factors, disease history, physical exam parameters, perioperative clinical data, and postoperative complication data.
Genetic analysis: targeted sequencing of selected SNPs associated with primary outcomes using PCR-based arrays or NGS/WGS. DNA from PBMCs will be collected from all participants, with potential additional sequencing pending external funding. A replication cohort of 525 patients from the INFLACOR study will be used for confirmatory analyses.
Epigenetic profiling: genome-wide epigenetic marker profiling from PBMCs in matched case-control subgroups (approximately n=300 per group) for participants who develop primary outcomes. DNA methylation will be analyzed to develop an epigenetic risk index and integrated with genetic and clinical data.
Transcriptomics: RNA-seq of PBMCs collected before surgery, as well as short-chain RNA (scRNA) profiling from urine samples collected pre- and postoperatively to identify early markers of AKI.
Proteomics and metabolomics: untargeted and targeted analyses of plasma collected preoperatively and at two postoperative time points (6 hours and postoperative day 3). These analyses aim to identify and validate early biomarkers of primary complications.
Laboratory diagnostics: serial measurement of selected laboratory markers relevant to early complications, such as serum creatinine, NGAL, cystatin C, and novel biomarkers (e.g., KIM) using ELISA.
Microbiota and microbiome: metabolomic and metagenomic sequencing analyses on fractionated stool samples to characterize gut bacterial composition, extracellular vesicles, and metabolite profiles, using GC-MS and LC-MS/MS.
Imaging data: routine preoperative imaging including transthoracic echocardiography (TTE) and coronary angiography.
Voice and video biomarkers: for participants developing POD, continuous bedside-acquired video, audio, and sensor data will be analyzed to identify voice and image biomarkers (e.g., MFCC parameters) associated with prodromal delirium. Machine-learning models will be developed to support real-time detection of POD-related features.
Analytical Approach
The study will use multistage regression, machine-learning techniques, and AI-based modeling to identify predictors of both primary and secondary outcomes. Analyses will integrate genetic, environmental, preoperative, and intraoperative factors. One aim is to enhance existing clinical risk calculators for postoperative morbidity and mortality, such as STS-ACSD and EuroSCORE. The study expects improved discrimination of predictive models, targeting ROC-AUC values >0.9 for mortality and >0.8 for morbidity.
A polygenic risk score will also be developed to evaluate genetic contribution to variation in primary outcomes.
Expected Impact
The integrated multi-omics and clinical approach is expected to identify new pathophysiological mechanisms underlying early postoperative complications and potentially support development of novel preventive therapies. The study aims to facilitate personalized perioperative diagnostic and therapeutic strategies by improving early identification of high-risk patients undergoing cardiac surgery.
- Conditions
- Postoperative Delirium (POD), Postoperative Bleeding, Acute Kidney Injury, Atrial Fibrillation (AF), Vasoplegia
- Being tested
- Multi-Omics Data and Clinical Data Collection
- Keywords
- Cardiac Surgery, Postoperative Complications, Atrial Fibrillation, Acute Kidney Injury, Postoperative Delirium, Vasoplegia, Biomarkers, Multi-omics, Risk Prediction, Epigenetics, genetics, microbiota, metabolomics
- Medical subject headings
- Emergence Delirium, Postoperative Hemorrhage, Acute Kidney Injury, Atrial Fibrillation, Vasoplegia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Omics Data and Clinical Data CollectionOther
Also called Biological Sample Collection
Collection of blood, urine, stool, imaging data, intraoperative data, and non-invasive digital recordings (voice and video) for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, laboratory, and clinical analyses. No therapeutic intervention is given. All procedures involve observational data and biospecimen collection before, during, and after elective cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| Elective Cardiac Surgery Patients | Adult men and women (≥18 years) undergoing elective cardiac surgery who provide informed consent are enrolled. Patients with a history of, or planned, solid organ or bone marrow transplantation are excluded. All participants are followed prospectively during and after surgery to determine the occurrence of early postoperative complications, including new-onset atrial fibrillation, acute kidney injury, postoperative delirium, vasoplegia, and postoperative bleeding, as well as in-hospital and 30-day mortality, duration of mechanical ventilation, and ICU and hospital length of stay. Receives: Other: Multi-Omics Data and Clinical Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
New-onset atrial fibrillation (NOAF)
Occurrence of new-onset atrial fibrillation after cardiac surgery, defined according to current ESC guidelines, using clinical data, ECG and centrally recorded rhythm data.
Measured: From end of surgery until hospital discharge, up to 14 days.
Acute kidney injury (AKI)
Occurrence of acute kidney injury after cardiac surgery, defined according to KDIGO criteria, using serial laboratory measurements (including serum creatinine and other kidney biomarkers).Early postoperative period after cardiac surgery during index hospitalization.
Measured: From end of surgery until hospital discharge, up to 14 days.
Postoperative delirium (POD)
Occurrence of postoperative delirium after cardiac surgery, defined according to DSM-V criteria and assessed with validated delirium scales (e.g., CAM-ICU or DOSS), clinical observation, and supporting data (including voice and image recordings in selected patients).
Measured: From end of surgery until hospital discharge, up to 14 days.
Vasoplegia
Occurrence of vasoplegia after cardiac surgery, identified from perioperative and postoperative hemodynamic and clinical data according to prespecified criteria in the protocol.
Measured: Perioperative period and postoperative hospitalization, up to 14 days.
Postoperative bleeding
Occurrence of significant postoperative bleeding after cardiac surgery, defined as blood loss >1000 mL in chest drains within 24 hours or the need for surgical re-exploration due to bleeding.
Measured: Within 24 hours after surgery and during hospitalization for re-exploration, up to 14 days.
Secondary outcomes (5)
In-hospital mortality
Death from any cause occurring during the index hospitalization after cardiac surgery.
Measured: From date of surgery until hospital discharge or death, up to 14 days.
30-day mortality
Death from any cause within 30 days after cardiac surgery, assessed through hospital records and follow-up.
Measured: 30 days after surgery.
Duration of mechanical ventilation
Total duration of postoperative invasive mechanical ventilation, measured in hours, based on clinical and ICU records.
Measured: From end of surgery until final extubation, up to 7 days.
ICU length of stay
Duration of postoperative stay in the intensive care unit, measured in days, based on clinical records.
Measured: From ICU admission after surgery until ICU discharge, up to 7 days.
Postoperative hospital length of stay
Total length of postoperative hospitalization, measured in days, based on clinical records.
Measured: From date of surgery until hospital discharge, up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Politechnika Gdańska, University of Gdańsk, Pomeranian Medical University Szczecin, Silesian University of Medicine, AGH University of Science and Technology, Krakow, Poland
- Responsible party
- Principal investigator, Maciej M. Kowalik, MD, PhD, DSc, Medical University of Gdansk
- Investigators
- Maciej M Kowalik, MD, PhD, Dsc, Study director, Medical University of Gdansk, Department of Anesthesiology and Intensive CareRadosław Owczuk, Prof. dr hab., Study chair, Medical University fo Gdańsk, Department of Anetshesiology and Intensive CareKowalik M Kowalik, MD, PhD, Dsc, Principal investigator, Medical University of Gdansk, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345403
- Sponsor's protocol ID
- KB/470/2025
- Other IDs
- 064/2025
- Acronym
- GENECARD
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual data planed for sharing will include: 1. anamnesis and structured forms derived data 2. comorbdities and chronic therapies 3. laboratory results of blood, urine and other bio specimen exams 4. genotyped SNP's associated with primary outcome measures 5. others
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENECARD - the Use of Genetic, Epigenetic, Metabolomic, Proteomic and Microbiotic Markers, Image and Voice Biomarker Analyses, and Pre- and Intraoperative Clinical Data - to Predict Early Complications After Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT07345403
- Acronym / sponsor ID
- GENECARD / KB/470/2025
- Conditions
- Postoperative Delirium (POD), Postoperative Bleeding, Acute Kidney Injury, Atrial Fibrillation (AF), Vasoplegia
- Keywords
- Cardiac Surgery, Postoperative Complications, Atrial Fibrillation, Acute Kidney Injury, Postoperative Delirium, Vasoplegia, Biomarkers, Multi-omics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Politechnika Gdańska, University of Gdańsk, Pomeranian Medical University Szczecin, Silesian University of Medicine, AGH University of Science and Technology, Krakow, Poland
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Jan 2026 (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.
The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients.
The main questions it aims to answer are:
Which biological and clinical markers are associated with: new-onset atrial fibrillation (NOAF), acute kidney injury (AKI), postoperative delirium (POD), vasoplegia, postoperative bleeding and 30-day mortality? Can combining these markers improve early prediction of postoperative complications compared with current clinical risk scores?
Researchers will analyze a wide range of data collected before, during, and after cardiac surgery and compare patients who develop early complications with those who do not to identify risk factors and early biomarkers.
Participants will:
Provide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing.
Undergo standard preoperative and intraoperative imaging and clinical assessments.
Allow collection of clinical data related to postoperative outcomes (For some participants) have voice and video recordings performed to help identify early signs of postoperative delirium.
This study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.
Detailed description
Single-center, prospective, translational, observational cohort study designed to identify markers that predict early postoperative complications in adult patients undergoing elective cardiac surgery. The study will analyze genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, imaging, voice, and detailed clinical data collected before, during, and after surgery. Approximately 2,000-3,000 participants will be enrolled between 2026 and 2029.
Study Objectives
The main objective is to determine whether selected biological and clinical markers can predict early postoperative complications, including:
New-onset atrial fibrillation (NOAF), Acute kidney injury (AKI), Postoperative delirium (POD), Vasoplegia, Postoperative bleeding 30-day mortality.
The study will use current clinical definitions: NOAF per ESC guidelines, AKI per KDIGO criteria, and POD per DSM-V, as well as validated delirium scales such as CAM-ICU or DOSS. Postoperative bleeding will be defined as >1000 mL drainage in 24 hours or the need for surgical re-exploration.
Secondary outcomes include in-hospital mortality, 30-day mortality, duration of mechanical ventilation, ICU length of stay, and total postoperative hospital length of stay.
Participants
Eligible participants are adult men and women undergoing elective cardiac surgery who provide informed consent. Exclusion criteria are age <18 years, lack of consent, and prior or planned organ or bone marrow transplantation.
Data and Sample Collection
The study will collect a broad set of data and biological materials, including:
Clinical data: detailed medical history, epidemiologic factors, disease history, physical exam parameters, perioperative clinical data, and postoperative complication data.
Genetic analysis: targeted sequencing of selected SNPs associated with primary outcomes using PCR-based arrays or NGS/WGS. DNA from PBMCs will be collected from all participants, with potential additional sequencing pending external funding. A replication cohort of 525 patients from the INFLACOR study will be used for confirmatory analyses.
Epigenetic profiling: genome-wide epigenetic marker profiling from PBMCs in matched case-control subgroups (approximately n=300 per group) for participants who develop primary outcomes. DNA methylation will be analyzed to develop an epigenetic risk index and integrated with genetic and clinical data.
Transcriptomics: RNA-seq of PBMCs collected before surgery, as well as short-chain RNA (scRNA) profiling from urine samples collected pre- and postoperatively to identify early markers of AKI.
Proteomics and metabolomics: untargeted and targeted analyses of plasma collected preoperatively and at two postoperative time points (6 hours and postoperative day 3). These analyses aim to identify and validate early biomarkers of primary complications.
Laboratory diagnostics: serial measurement of selected laboratory markers relevant to early complications, such as serum creatinine, NGAL, cystatin C, and novel biomarkers (e.g., KIM) using ELISA.
Microbiota and microbiome: metabolomic and metagenomic sequencing analyses on fractionated stool samples to characterize gut bacterial composition, extracellular vesicles, and metabolite profiles, using GC-MS and LC-MS/MS.
Imaging data: routine preoperative imaging including transthoracic echocardiography (TTE) and coronary angiography.
Voice and video biomarkers: for participants developing POD, continuous bedside-acquired video, audio, and sensor data will be analyzed to identify voice and image biomarkers (e.g., MFCC parameters) associated with prodromal delirium. Machine-learning models will be developed to support real-time detection of POD-related features.
Analytical Approach
The study will use multistage regression, machine-learning techniques, and AI-based modeling to identify predictors of both primary and secondary outcomes. Analyses will integrate genetic, environmental, preoperative, and intraoperative factors. One aim is to enhance existing clinical risk calculators for postoperative morbidity and mortality, such as STS-ACSD and EuroSCORE. The study expects improved discrimination of predictive models, targeting ROC-AUC values >0.9 for mortality and >0.8 for morbidity.
A polygenic risk score will also be developed to evaluate genetic contribution to variation in primary outcomes.
Expected Impact
The integrated multi-omics and clinical approach is expected to identify new pathophysiological mechanisms underlying early postoperative complications and potentially support development of novel preventive therapies. The study aims to facilitate personalized perioperative diagnostic and therapeutic strategies by improving early identification of high-risk patients undergoing cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Cardiac Surgery Patients | – | Other: Multi-Omics Data and Clinical Data CollectionAdult men and women (≥18 years) undergoing elective cardiac surgery who provide informed consent are enrolled. Patients with a history of, or planned, solid organ or bone marrow transplantation are excluded. All participants are followed prospectively during and after surgery to determine the occurrence of early postoperative complications, including new-onset atrial fibrillation, acute kidney injury, postoperative delirium, vasoplegia, and postoperative bleeding, as well as in-hospital and 30-day mortality, duration of mechanical ventilation, and ICU and hospital length of stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery at a single center. Participants include men and women who consent to provide clinical data and biospecimens for analysis. Individuals under 18 years of age or with prior or planned organ or bone marrow transplantation are excluded.
Key inclusion criteria (3 listed)
- Adults (≥18 years old)
- Undergoing elective cardiac surgery
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- Age below 18 years
- Lack of informed consent
- Prior or planned solid organ transplantation
- Prior or planned bone marrow transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Omics Data and Clinical Data CollectionAlso: Biological Sample CollectionCollection of blood, urine, stool, imaging data, intraoperative data, and non-invasive digital recordings (voice and video) for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, laboratory, and clinical analyses. No therapeutic intervention is given. All procedures involve observational data and biospecimen collection before, during, and after elective cardiac surgery. | Other | Elective Cardiac Surgery Patients |
Primary outcome
New-onset atrial fibrillation (NOAF)
Time frame: From end of surgery until hospital discharge, up to 14 days.
Occurrence of new-onset atrial fibrillation after cardiac surgery, defined according to current ESC guidelines, using clinical data, ECG and centrally recorded rhythm data.
Acute kidney injury (AKI)
Time frame: From end of surgery until hospital discharge, up to 14 days.
Occurrence of acute kidney injury after cardiac surgery, defined according to KDIGO criteria, using serial laboratory measurements (including serum creatinine and other kidney biomarkers).Early postoperative period after cardiac surgery during index hospitalization.
Postoperative delirium (POD)
Time frame: From end of surgery until hospital discharge, up to 14 days.
Occurrence of postoperative delirium after cardiac surgery, defined according to DSM-V criteria and assessed with validated delirium scales (e.g., CAM-ICU or DOSS), clinical observation, and supporting data (including voice and image recordings in selected patients).
Vasoplegia
Time frame: Perioperative period and postoperative hospitalization, up to 14 days.
Occurrence of vasoplegia after cardiac surgery, identified from perioperative and postoperative hemodynamic and clinical data according to prespecified criteria in the protocol.
Postoperative bleeding
Time frame: Within 24 hours after surgery and during hospitalization for re-exploration, up to 14 days.
Occurrence of significant postoperative bleeding after cardiac surgery, defined as blood loss >1000 mL in chest drains within 24 hours or the need for surgical re-exploration due to bleeding.
5 secondary outcomes
In-hospital mortality
Time frame: From date of surgery until hospital discharge or death, up to 14 days.
30-day mortality
Time frame: 30 days after surgery.
Duration of mechanical ventilation
Time frame: From end of surgery until final extubation, up to 7 days.
ICU length of stay
Time frame: From ICU admission after surgery until ICU discharge, up to 7 days.
Postoperative hospital length of stay
Time frame: From date of surgery until hospital discharge, up to 14 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual data planed for sharing will include: 1. anamnesis and structured forms derived data 2. comorbdities and chronic therapies 3. laboratory results of blood, urine and other bio specimen exams 4. genotyped SNP's associated with primary outcome measures 5. others
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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.
Maciej M Kowalik, MD, PhD, Dsc study director
Medical University of Gdansk, Department of Anesthesiology and Intensive Care
Radosław Owczuk, Prof. dr hab. study chair
Medical University fo Gdańsk, Department of Anetshesiology and Intensive Care
Kowalik M Kowalik, MD, PhD, Dsc principal investigator
Medical University of Gdansk, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium (POD) and Postoperative Bleeding, run by Medical University of Gdansk at 1 site in Poland.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maciej Kowalik, MD, PhD, DSc (+48585846109, mkowalik@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New-onset atrial fibrillation (NOAF) (time frame: From end of surgery until hospital discharge, up to 14 days.). The study lists 5 primary outcomes in all. 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 15 Jan 2026.