Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump

Conditions
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Delirium

Intervention / Treatment
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* Other: evaluation of delirium with CAM-ICU Score


Participation Criteria
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Eligibility Criteria
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Inhibitors of serotoninergic reuptake on Inclusion Criteria: 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 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) 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)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inhibitors of serotoninergic reuptake on<br>patients with a diagnosis of depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake drugs excluding neurodegenerative diseases and on treatment with antidepressants for more than three months. Intervention: evaluation of the presence of postoperative delirium with the CAM-ICU score upon awakening and for the following 48 hours. | Other: evaluation of delirium with CAM-ICU Score<br>* the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject<br>|
| Inhibitors of serotoninergic reuptake off<br>patients without a diagnosis of depressive syndrome requiring treatment with Inhibitors of serotoninergic reuptake drugs excluding neurodegenerative diseases and not in treatment with antidepressants. Intervention: evaluation of the presence of postoperative delirium with the CAM-ICU score upon awakening and for the following 48 hours. | Other: evaluation of delirium with CAM-ICU Score<br>* the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of postoperative delirium | presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours | 4 june 2020 to 4 june 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with ICU-Length of Stay | Correlation with ICU-Length of Stay | 4 june 2020 to 4 june 2021 | 
| correlation with Hospital-Length of Stay | correlation with Hospital-Length of Stay | 4 june 2020 to 4 june 2021 | 
| Bleeding | measure of bleeding in ml / day | 4 june 2020 to 4 june 2021 | 
| re-operated patient | Number of re-operated patient | 4 june 2020 to 4 june 2021 | 
| mechanical ventilation in intensive care | number of patients who required mechanical ventilation in the ICU | 4 june 2020 to 4 june 2021 | 
| mortality | mortality at 28 days | 4 june 2020 to 4 june 2021 | 
| infections | number and type of infections that occurred following the operation | 4 june 2020 to 4 june 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Postoperative, CAM-ICU Score