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

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Status: Completed

Conditions: Delirium

Treatments: Other: evaluation of delirium with CAM-ICU Score

Study type: Observational

Funder types: Other

Identifiers

NCT05089097

ASO.Cch.19.01

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

152 participants in 2 patient groups

Inhibitors of serotoninergic reuptake on

Description:

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.

Treatment:

Other: evaluation of delirium with CAM-ICU Score

Inhibitors of serotoninergic reuptake off

Description:

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.

Treatment:

Other: evaluation of delirium with CAM-ICU Score