Assessment of Postoperative Delirium With CAM ICU Score in Patients Treated With Serotoninergic Reuptake (SSRI) Inhibitors and Undergoing Intervention of Heart Surgery on Pump
NCT ID: NCT05089097
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
152 participants
OBSERVATIONAL
2020-06-04
2021-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Inhibitors of serotoninergic reuptake on
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.
evaluation of delirium with CAM-ICU Score
the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject
Inhibitors of serotoninergic reuptake off
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.
evaluation of delirium with CAM-ICU Score
the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject
Interventions
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evaluation of delirium with CAM-ICU Score
the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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)
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
OTHER
Responsible Party
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Locations
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Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Countries
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Other Identifiers
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ASO.Cch.19.01
Identifier Type: -
Identifier Source: org_study_id