Postoperative DeliriumNCT04828902
Incidence of Postoperative Delirium After Cardiac Surgery in Adults.
An observational study of Postoperative Delirium and Adult Cardiac Surgery, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Postoperative delirium is an acute syndrome of mental deterioration characterized by acute onset and fluctuating course during the day. Very frequent delirium is a presage of other serious comorbidities i.e.: sepsis, acute kidney injury, circulatory and/or respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium, Adult Cardiac Surgery, Covid19
- What is being tested?
- cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 610 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2021to 31 Aug 2025
- 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: All adult patients undergoing elective/emergency cardiac surgery will be considered eligible.
Who may be able to join
- Adult patients (>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study.
Who cannot join
- Deny to sign or absence of an informed consent.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Cadiac Anesthesiology, Medical University of Gdańsk
Gdansk, Pomeranian Voivodeship, 80-211
About this study
Official title: Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study
Postoperative delirium is an acute syndrome of mental deterioration characterized by acute onset and fluctuating course during the day. Very frequent delirium is a presage of other serious comorbidities i.e.: sepsis, acute kidney injury, circulatory and/or respiratory failure. A detailed knowledge of symptoms and early diagnose of delirium increase the chances of early therapy. To what extent the occurrence of postoperative delirium influences hospital therapy in the Cardiac Surgical Postoperative ICU in University Clinical Centre in Gdańsk is unknown so far.
Read the detailed description
Study type: prospective, observational cohort study. Facility: tertiary, university hospital Methods: Patients will undergo routine, continuous observation for symptoms of delirium by a trained nursing staff. Occurrence of delirium, Delirium Observation Screening Scale (DOSS) grading, and therapy will by annotated on case record forms (CRFs) every 12 hours. Additionally, collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, body mass index (BMI), angiotensin converting enzyme (ACE) inhibitors / angiotensin receptor blockers (ARBs) therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, corona virus disease 2019 (COVID19) infection and/or vaccination; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, hours on mechanical ventilation (HOV), number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation (CPR), renal replacement therapy (RRT), mechanical circulatory support (MCS), duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.
Statistical methods: Delirium morbidity and risk will be calculated from two-by-two table. Associations between delirium and secondary outcome measures will be evaluated by simple and logistic regression with use of ANOVA test for continuous variables with homogeneous distribution, or Kruskal-Wallis test for continuous variables with non-homogeneous distribution, or categorical variables. Significant will be considered results with p<0.05.
A period of one year was assumed sufficient to draw conclusions on the primary endpoints of the study.
- Conditions
- Postoperative Delirium, Adult Cardiac Surgery, Covid19
- Being tested
- cardiac surgery
- Keywords
- postoperative delirium, cardiac surgery, Covid19
- Medical subject headings
- Emergence Delirium, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryProcedure or surgery
Also called cabg, valve surgery, aorta surgery, heart transplant
Any heart surgery on or without cardiopulmonary bypass performed under general anesthesia in the Cardiac Surgical Department, Medical University of Gdańsk.
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium incidence and risk
Incidence and risk of postoperative delirium
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Risk factors of delirium.
collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, BMI, ACE/ARBs therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, COVID19 and/or vaccination for it; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, direct coercion, length of mechanical ventilation, number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation, renal replacement therapy, mechanical circulatory support, duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Association between delirium and length of stay in ICU (LOS-ICU).
Association between delirium and length of stay in ICU (LOS-ICU).
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Secondary outcomes (12)
DOSS
Associations between delirium and mean DOSS
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Hospital-LOS
Association between delirium and hospital-LOS
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Prolonged sedation, antipsychotic therapy and surgical re-intervention.
Association between delirium and prolonged sedation, antipsychotic therapy, surgical reintervention.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Hours on ventilator.
Association between delirium and HOV.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Intubations
Association between delirium and number of tracheal intubations.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Consciousness disorders
Association between delirium and length of consciousness disorders.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Transfusions
Association between delirium and blood product transfusions.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
CPR, RRT, MCS
Association between delirium and CPR, RRT, and MCS.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
Catecholamines
Association between delirium and duration of catecholamine support.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
ICU readmissions
Association between delirium and ICU readmissions.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
New antibiotic
Association between delirium and new antibiotic therapy.
Measured: Through hospitalisation in Postop-ICU - an average of 2 days
30-day mortality
Association between delirium and 30-day mortality
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2021
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies 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
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej M. Kowalik, MD, PhD, DSc, Medical University of Gdansk
- Investigators
- Romuald Lango, Prof.dr.hab., Study chair, Medical University of Gdańsk, Department of Cardiac AnesthesiologyMaciej Kowalik, Dr hab., Study director, Medical University of Gdańsk, Department of Cardiac AnesthesiologyPawel Kozak, Mgr. Piel., Principal investigator, Medical University of Gdańsk, Department of Cardiac Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828902
- Sponsor's protocol ID
- NKBBN/442/2020
- Status last verified
- May 2026
- First submitted
- 21 Mar 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized patients data are planned to be uploaded into a public data repository (ZENODO.com) after data completion.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04828902
- Acronym / sponsor ID
- NKBBN/442/2020
- Conditions
- Postoperative Delirium, Adult Cardiac Surgery, Covid19
- Keywords
- postoperative delirium, cardiac surgery, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 2 Apr 2021 (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.
Postoperative delirium is an acute syndrome of mental deterioration characterized by acute onset and fluctuating course during the day. Very frequent delirium is a presage of other serious comorbidities i.e.: sepsis, acute kidney injury, circulatory and/or respiratory failure. A detailed knowledge of symptoms and early diagnose of delirium increase the chances of early therapy. To what extent the occurrence of postoperative delirium influences hospital therapy in the Cardiac Surgical Postoperative ICU in University Clinical Centre in Gdańsk is unknown so far.
Detailed description
Study type: prospective, observational cohort study. Facility: tertiary, university hospital Methods: Patients will undergo routine, continuous observation for symptoms of delirium by a trained nursing staff. Occurrence of delirium, Delirium Observation Screening Scale (DOSS) grading, and therapy will by annotated on case record forms (CRFs) every 12 hours. Additionally, collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, body mass index (BMI), angiotensin converting enzyme (ACE) inhibitors / angiotensin receptor blockers (ARBs) therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, corona virus disease 2019 (COVID19) infection and/or vaccination; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, hours on mechanical ventilation (HOV), number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation (CPR), renal replacement therapy (RRT), mechanical circulatory support (MCS), duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.
Statistical methods: Delirium morbidity and risk will be calculated from two-by-two table. Associations between delirium and secondary outcome measures will be evaluated by simple and logistic regression with use of ANOVA test for continuous variables with homogeneous distribution, or Kruskal-Wallis test for continuous variables with non-homogeneous distribution, or categorical variables. Significant will be considered results with p<0.05.
A period of one year was assumed sufficient to draw conclusions on the primary endpoints of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing elective/emergency cardiac surgery will be considered eligible.
Key inclusion criteria (1 listed)
- Adult patients (>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Deny to sign or absence of an informed consent.
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 |
|---|---|---|
| cardiac surgeryAlso: cabg, valve surgery, aorta surgery, heart transplantAny heart surgery on or without cardiopulmonary bypass performed under general anesthesia in the Cardiac Surgical Department, Medical University of Gdańsk. | Procedure or surgery | – |
Primary outcome
Delirium incidence and risk
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Incidence and risk of postoperative delirium
Risk factors of delirium.
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
collected will be known risk factors of delirium: schedule type, age, arterial hypertension, atrial fibrillation, BMI, ACE/ARBs therapy, hearing loss, dementia, peripheral artery disease, myocardial infarction, depression, diabetes, COVID19 and/or vaccination for it; and outcome data: hospital-LOS, prolonged sedation, antipsychotic therapy, surgical reintervention, direct coercion, length of mechanical ventilation, number of tracheal intubations, length of consciousness disorders, blood product transfusions, cardiopulmonary resuscitation, renal replacement therapy, mechanical circulatory support, duration of catecholamine support, ICU readmissions, new antibiotic therapies, 30-day mortality.
Association between delirium and length of stay in ICU (LOS-ICU).
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Association between delirium and length of stay in ICU (LOS-ICU).
12 secondary outcomes
DOSS
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Hospital-LOS
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Prolonged sedation, antipsychotic therapy and surgical re-intervention.
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Hours on ventilator.
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Intubations
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Consciousness disorders
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Transfusions
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
CPR, RRT, MCS
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
Catecholamines
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
ICU readmissions
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
New antibiotic
Time frame: Through hospitalisation in Postop-ICU - an average of 2 days
30-day mortality
Time frame: 30 days after operation
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 19 May 2026.
- Individual participant dataSharing planned: Undecided. Anonymized patients data are planned to be uploaded into a public data repository (ZENODO.com) after data completion.
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Romuald Lango, Prof.dr.hab. study chair
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Maciej Kowalik, Dr hab. study director
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Pawel Kozak, Mgr. Piel. principal investigator
Medical University of Gdańsk, Department of Cardiac Anesthesiology
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 and Adult Cardiac Surgery, 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 1 inclusion and 1 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 19 May 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?
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?
Delirium incidence and risk (time frame: Through hospitalisation in Postop-ICU - an average of 2 days). The study lists 3 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 19 May 2026.