Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Delirium
- Sponsor
- Medical University of Gdansk
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Delirium incidence and risk
- Last Updated
- 5 years ago
Overview
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.
Investigators
Maciej M. Kowalik, MD, PhD
Promotor, Dr hab. n. med. Maciej Michał Kowalik
Medical University of Gdansk
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- DOSS(Through hospitalisation in Postop-ICU - an average of 2 days)
- Hospital-LOS(Through hospitalisation in Postop-ICU - an average of 2 days)
- Hours on ventilator.(Through hospitalisation in Postop-ICU - an average of 2 days)
- Intubations(Through hospitalisation in Postop-ICU - an average of 2 days)
- Consciousness disorders(Through hospitalisation in Postop-ICU - an average of 2 days)
- Transfusions(Through hospitalisation in Postop-ICU - an average of 2 days)
- CPR, RRT, MCS(Through hospitalisation in Postop-ICU - an average of 2 days)
- Catecholamines(Through hospitalisation in Postop-ICU - an average of 2 days)
- ICU readmissions(Through hospitalisation in Postop-ICU - an average of 2 days)
- New antibiotic(Through hospitalisation in Postop-ICU - an average of 2 days)
- 30-day mortality(30 days after operation)
- Prolonged sedation, antipsychotic therapy and surgical re-intervention.(Through hospitalisation in Postop-ICU - an average of 2 days)