Incidence of Postoperative Delirium After Cardiac Surgery in Adults.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study

Conditions
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Postoperative Delirium, Adult Cardiac Surgery, Covid19

Intervention / Treatment
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* Procedure: cardiac surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study. Exclusion Criteria: Deny to sign or absence of an informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cardiac surgery|Any heart surgery on or without cardiopulmonary bypass performed under general anesthesia in the Cardiac Surgical Department, Medical University of Gdańsk.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium incidence and risk | Incidence and risk of postoperative delirium | 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. | 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). | Through hospitalisation in Postop-ICU - an average of 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOSS | Associations between delirium and mean DOSS | Through hospitalisation in Postop-ICU - an average of 2 days | 
| Hospital-LOS | Association between delirium and hospital-LOS | 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. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| Hours on ventilator. | Association between delirium and HOV. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| Intubations | Association between delirium and number of tracheal intubations. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| Consciousness disorders | Association between delirium and length of consciousness disorders. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| Transfusions | Association between delirium and blood product transfusions. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| CPR, RRT, MCS | Association between delirium and CPR, RRT, and MCS. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| Catecholamines | Association between delirium and duration of catecholamine support. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| ICU readmissions | Association between delirium and ICU readmissions. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| New antibiotic | Association between delirium and new antibiotic therapy. | Through hospitalisation in Postop-ICU - an average of 2 days | 
| 30-day mortality | Association between delirium and 30-day mortality | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative delirium, cardiac surgery, Covid19