Incidence of Postoperative Delirium After Cardiac Surgery in Adults - a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Delirium incidence and risk
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 y.a.), undergoing cardiac surgery, who will sign an informed consent to participate in the study.
排除标准
- •Deny to sign or absence of an informed consent.
结局指标
主要结局
Delirium incidence and risk
时间窗: Through hospitalisation in Postop-ICU - an average of 2 days
Incidence and risk of postoperative delirium
Risk factors of delirium.
时间窗: 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).
时间窗: Through hospitalisation in Postop-ICU - an average of 2 days
Association between delirium and length of stay in ICU (LOS-ICU).
次要结局
- 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)
研究者
Maciej M. Kowalik, MD, PhD
Promotor, Dr hab. n. med. Maciej Michał Kowalik
Medical University of Gdansk