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

Completed

• Conditions: Delirium
• Interventions: Other: evaluation of delirium with CAM-ICU Score

• Registration Number: NCT05089097
• Lead Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-04
• Primary Completion: 2021-06-04
• Study Completion: 2021-09-15
• Status Verified: 2021-10
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inhibitors of serotoninergic reuptake off	evaluation of delirium with CAM-ICU Score	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.
Inhibitors of serotoninergic reuptake on	evaluation of delirium with CAM-ICU Score	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.

Primary Outcome Measures

Name	Time	Method
Presence/absence of postoperative delirium	4 june 2020 to 4 june 2021	presence / absence of postoperative delirium, assessed with CAM-ICU, from awakening and for the following 48 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy