Assessment of Postoperative Delirium With CAM ICU Score i... | NCT05089097

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: evaluation of delirium with CAM-ICU Score
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.	Other: evaluation of delirium with CAM-ICU Score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
evaluation of delirium with CAM-ICU Score	Other	the CAM-ICU score is an evaluation tool to verify the presence or absence of delirium in a subject	Inhibitors of serotoninergic reuptake off

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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)

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D019965	Neurocognitive Disorders
D001523	Mental Disorders