Incidence of Postoperative Delirium After Cardiac Surgery in Adults.
- Conditions
- Postoperative DeliriumAdult Cardiac SurgeryCovid19
- Registration Number
- NCT04828902
- Lead Sponsor
- Medical University of Gdansk
- Brief 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- Adult patients (>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study.
- Deny to sign or absence of an informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delirium incidence and risk Through hospitalisation in Postop-ICU - an average of 2 days Incidence and risk of postoperative delirium
Risk factors of delirium. 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). Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and length of stay in ICU (LOS-ICU).
- Secondary Outcome Measures
Name Time Method DOSS Through hospitalisation in Postop-ICU - an average of 2 days Associations between delirium and mean DOSS
Hospital-LOS Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and hospital-LOS
Hours on ventilator. Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and HOV.
Intubations Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and number of tracheal intubations.
Consciousness disorders Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and length of consciousness disorders.
Transfusions Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and blood product transfusions.
CPR, RRT, MCS Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and CPR, RRT, and MCS.
Catecholamines Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and duration of catecholamine support.
ICU readmissions Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and ICU readmissions.
New antibiotic Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and new antibiotic therapy.
30-day mortality 30 days after operation Association between delirium and 30-day mortality
Prolonged sedation, antipsychotic therapy and surgical re-intervention. Through hospitalisation in Postop-ICU - an average of 2 days Association between delirium and prolonged sedation, antipsychotic therapy, surgical reintervention.
Trial Locations
- Locations (1)
Department of Cadiac Anesthesiology, Medical University of Gdańsk
🇵🇱Gdańsk, Pomorskie, Poland