NCT05089097已完成不适用
Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2020年6月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Presence/absence of postoperative delirium
研究概览
简要总结
The study aims to observe the presence of postoperative delirium in patients undergoing elective cardiac surgery, without changing the pharmacological prescriptions of the enrolled patients and the procedures carried out by normal clinical practice.
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
- •patients over 18 years old
- •patients undergoing elective cardiac surgery
- •patients diagnosed with depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake excluding neurodegenerative diseases
- •patients on antidepressant therapy for more than 3 months at the time of enrollment
排除标准
- •absence of written informed consent to the study
- •patients undergoing non-elective and emergency cardiac surgery
- •patients undergoing off pump surgery
- •patients with depression not on therapy
- •patients with existing malignancies
- •patients with acute infections in progress
- •patients with previous stroke, cerebral haemorrhage with relics
- •patients with acquired and congenital metabolic pathologies with CNS alterations
- •Patients with acute and / or chronic renal failure according to RIFLE score (exclude only F-L-E)
- •Patients with acute and / or chronic hepatic insufficiency according to Child - Pugh score <6 (but without encephalopathy);
- •Patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium);
- •Patients with previous or current drug and / or alcohol abuse
- •pregnant or postpartum period patients (6 months after delivery)
- •Inhibitors of serotoninergic reuptake off
- •Inclusion Criteria:
- •patients over 18 years old
- •patients undergoing elective cardiac surgery
- •patients without a diagnosis of depressive and psychiatric illness requiring treatment with psychoactive drugs to the exclusion of neurodegenerative diseases
- •Exclusion Criteria:
- •absence of written informed consent to the study
- •patients undergoing non-elective and emergency cardiac surgery
- •patients undergoing off pump surgery
- •patients with depression not on therapy
- •patients with existing malignancies
- •patients with acute infections in progress
- •patients with previous stroke, cerebral haemorrhage with relics
- •patients with acquired and congenital metabolic pathologies with CNS alterations
- •Patients with acute and / or chronic renal failure according to RIFLE score (exclude only F-L-E)
- •Patients with acute and / or chronic hepatic insufficiency according to Child - Pugh score <6 (but without encephalopathy);
- •Patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium);
- •Patients with previous or current drug and / or alcohol abuse
- •pregnant or postpartum period patients (6 months after delivery)
结局指标
主要结局
Presence/absence of postoperative delirium
时间窗: 4 june 2020 to 4 june 2021
presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours
次要结局
- re-operated patient(4 june 2020 to 4 june 2021)
- Correlation with ICU-Length of Stay(4 june 2020 to 4 june 2021)
- Bleeding(4 june 2020 to 4 june 2021)
- correlation with Hospital-Length of Stay(4 june 2020 to 4 june 2021)
- mechanical ventilation in intensive care(4 june 2020 to 4 june 2021)
- infections(4 june 2020 to 4 june 2021)
- mortality(4 june 2020 to 4 june 2021)
研究者
研究点 (1)
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